Apparatus and method for manufacturing customized 3d-printed upper-jaw fixation device

Abstract

The present invention relates to an apparatus and a method for manufacturing a customized 3D-printed upper-jaw fixation device. The apparatus for manufacturing a customized 3D-printed upper-jaw fixation device according to an embodiment of the present invention may comprise: a scanning unit for collecting a digital impression of an oral cavity through an intraoral scanner; a design unit for setting an engagement of a clasp by considering positions of teeth and a buccal surface in the digital impression; an output setting unit for setting a thickness and applying an offset to the digital impression in which the clasp engagement is set so as to generate an output file; and a printing unit for outputting the upper-jaw fixation device on the basis of the output file.

Description

Manufacturing device and method for a customized 3D printing fixation device

[0001] The present invention relates to a device and method for manufacturing a customized 3D printing fixation device.

[0002] Among the various periodontal procedures, soft tissue grafting is widely used clinically to transplant soft tissue into areas of gingival deficiency around teeth and implants. While autologous soft tissue grafting is considered a highly predictable procedure, it can be uncomfortable for patients due to the need to harvest gingival tissue from the palate and other areas of the oral cavity during the procedure.

[0003] Attempts have been made to address this issue using soft tissue substitutes. However, these methods still suffer from the drawback of not guaranteeing long-term stability compared to methods utilizing autologous tissue harvesting.

[0004] (Prior art literature)

[0005] (Patent Document)

[0006] (Patent Document 1) Republic of Korea Patent Publication No. 10-2023-0165994 (published on December 6, 2023)

[0007] The purpose of the present invention is to provide a device and method for manufacturing a customized 3D printing upper fixation device that can scan the inside of a user's oral cavity and produce a customized upper fixation device.

[0008] In another aspect, the present invention aims to provide a device and method for manufacturing a customized 3D printing fixation device that can be applied to the human body for a long period of time through a fixation device composed of a biocompatible material.

[0009] According to an embodiment of the present invention for solving the above technical problem, a manufacturing device for a customized 3D printing upper fixation device may include a scanning unit that collects a digital impression of an oral cavity through an oral scanner, a design unit that sets a connection of a clasp by considering the positions of teeth and a buccal surface in the digital impression, an output setting unit that applies an offset to the digital impression in which the connection of the clasp is set and sets a thickness to generate an output file, and a printing unit that outputs the upper fixation device based on the output file.

[0010] Additionally, the scanning unit can collect the digital impression including the area from the occlusal surface of the posteriormost tooth to the occlusal surface of the molar of the opposite arch.

[0011] In addition, the design section can set the connection of the clasp to connect from an area on the distal side of the posteriormost tooth to an area on the buccal side.

[0012] In addition, the output setting unit can generate the output file by applying an offset of a preset size to the digital impression and applying a thickness of a preset size.

[0013] In addition, the output setting section can generate the output file by reinforcing the thickness of the short clasp located at both ends of the clasp.

[0014] According to another embodiment of the present invention for solving the above technical problem, a method for manufacturing a customized 3D printing fixation device may include (a) a step in which a scanning unit collects a digital impression of an oral cavity through an oral scanner, (b) a step in which a design unit sets a connection of a clasp by considering the positions of teeth and a buccal surface in the digital impression, (c) a step in which an output setting unit applies an offset to the digital impression in which the connection of the clasp is set and sets a thickness to generate an output file, and (d) a step in which a printing unit outputs a fixation device based on the output file.

[0015] Additionally, the step (a) may collect the digital impression including the area from the occlusal surface of the posteriormost tooth to the occlusal surface of the molar of the opposite arch.

[0016] In addition, the step (b) above can set the connection of the clasp to connect from one area on the distal side of the posteriormost tooth to one area on the buccal side.

[0017] In addition, the step (c) may generate the output file by applying an offset of a preset size to the digital impression and applying a thickness of a preset size.

[0018] In addition, the step (c) above can generate the output file by reinforcing the thickness of the short clasp located at both ends of the clasp.

[0019] According to one embodiment of the present invention described above, a device and method for manufacturing a customized 3D printing upper fixation device can be provided that can scan the inside of a user's oral cavity to produce a customized upper fixation device.

[0020] In addition, the present invention can provide a device and method for manufacturing a customized 3D printing fixation device that can be applied to the human body for a long period of time through a fixation device composed of a biocompatible material.

[0021] FIG. 1 is a drawing illustrating the configuration of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0022] FIG. 2 is a drawing showing an example of a digital impression in which a clasp connection of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention is set.

[0023] FIG. 3 is a drawing showing an example of a digital impression with an offset applied to a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0024] FIG. 4 is a drawing showing an example of an output file indicating the thickness setting and occlusal surface of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0025] FIG. 5 is a drawing illustrating an example of reinforcing the clasp thickness of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0026] FIG. 6 is a drawing showing an example of an output file of a manufacturing device for a customized 3D printing fixing device according to one embodiment of the present invention.

[0027] FIG. 7 is a drawing illustrating an example of a resin profile setting of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0028] FIG. 8 is a drawing showing an example of a sliced ​​output file of a manufacturing device for a customized 3D printing fixing device according to one embodiment of the present invention.

[0029] FIGS. 9 to 11 are drawings showing examples of 3D printed fixing devices of a manufacturing device for a customized 3D printing fixing device according to one embodiment of the present invention.

[0030] FIGS. 12 to 14 are drawings showing the surgical process using a fixation device manufactured through a device for manufacturing a customized 3D printing fixation device according to one embodiment of the present invention.

[0031] FIG. 15 is a drawing illustrating a flow chart of a method for manufacturing a customized 3D printing fixation device according to one embodiment of the present invention.

[0032] The purposes and effects of the present invention, as well as the technical configurations for achieving them, will become clearer with reference to the embodiments described in detail below, along with the accompanying drawings. In describing the present invention, detailed descriptions of known functions or configurations will be omitted if they are deemed to unnecessarily obscure the gist of the invention.

[0033] However, this is not intended to limit the present invention to a specific embodiment, but should be understood to include all modifications, equivalents, or substitutes included in the spirit and technical scope of the present invention.

[0034] And the terms described below are terms defined in consideration of the functions in the present invention, and these may vary depending on the intention or custom of the user or operator.

[0035] However, the present invention is not limited to the embodiments disclosed below and can be implemented in various different forms. These embodiments are provided solely to ensure complete disclosure of the present invention and to fully inform those skilled in the art of the invention of the scope of the invention. The present invention is defined solely by the scope of the claims. Therefore, such definitions should be based on the contents of this specification.

[0036] The terminology used in this application is only used to describe specific embodiments and is not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this application, it should be understood that the terms "comprise" or "have" indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but do not preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0037] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0038] Hereinafter, with reference to the attached drawings, preferred embodiments of the present invention will be described in more detail. In order to facilitate an overall understanding in describing the present invention, identical reference numerals are used for identical components in the drawings, and redundant descriptions of identical components are omitted.

[0039] FIG. 1 is a drawing illustrating the configuration of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0040] Referring to FIG. 1, a device (100) for manufacturing a customized 3D printing fixation device may include a scanning unit (110), a design unit (120), an output setting unit (130), and a printing unit (140). The device (100) for manufacturing a customized 3D printing fixation device according to one embodiment of the present invention is for manufacturing a fixation device used in soft tissue grafting, which transplants soft tissue to areas where gingiva is insufficient around teeth and implants in periodontal plastic surgery.

[0041] A lack of soft tissue around teeth and implants can easily lead to plaque buildup and difficulty maintaining oral hygiene. Poor oral hygiene can threaten the health of teeth and implants. Therefore, soft tissue grafting is performed to address these issues.

[0042] Autologous soft tissue grafting presents some inconveniences for patients, as it requires harvesting gingival tissue from the palate and other areas of the oral cavity during the procedure. Consequently, attempts have been made to use soft tissue substitutes instead of autologous gingival tissue, but these methods have limitations, such as not guaranteeing long-term stability compared to autologous tissue.

[0043] In addition, although existing surgical stents (fixation devices) contribute to reducing pain and bleeding at the donor site after tissue extraction, they still have the disadvantage of making pronunciation and chewing difficult due to wearing the oral device.

[0044] In particular, the existing fixed device used a method of attaching a periodontal pad after surgical suturing. However, this method made it difficult to control bleeding due to the lack of additional suturing and compression, and frequent detachment resulted in a foreign body sensation and discomfort. The method of protecting the wound with light-curing resin also resulted in frequent detachment due to the difficulty in drying the gingiva. In addition, a method of manufacturing a plaster model by taking an impression of the oral cavity, and then manufacturing the shape using heat and pressure using a thin transparent sheet and attaching it using the curvature of the teeth has been attempted. However, this method also had a complicated manufacturing process and covered the occlusal surface, which caused great inconvenience in eating and pronunciation.

[0045] Accordingly, a manufacturing device (100) for a customized 3D printing upper fixation device according to one embodiment of the present invention proposes a manufacturing device for manufacturing a new type of upper fixation device that improves eating and pronunciation, and a manufacturing device capable of manufacturing a user-customized upper fixation device through an oral scanner and 3D printing.

[0046] The scanning unit (110) can collect a digital impression of the oral cavity using an oral scanner. The scanning unit (110) can collect a digital impression that includes the area from the occlusal surface of the most posterior tooth to the occlusal surface of the molar of the opposite arch. For example, the scanning unit (110) can collect a digital impression using computer-aided design software (Meshmixer, v3.5), but is not limited to the above program.

[0047] Specifically, the posteriormost tooth is the molar (or in some cases, a premolar) located at the innermost part of the mouth, and the scanning unit (110) can scan the occlusal surface starting from the occlusal surface of the molar through the incisors to the molar of the opposite arch. Thereafter, the buccal and palatal surfaces of the teeth can be scanned.

[0048] At this time, the scanning unit (110) can perform multiple scans until it is confirmed that the gingiva on the distal and buccal sides of the last molar are clearly visible to the naked eye. In addition, in the case of the palate, multiple scans can be performed until the vibration line is clearly visible. The scanned image data, i.e., the digital impression, can be saved in an STL (Stereolithography) file format.

[0049] FIG. 2 is a drawing showing an example of a digital impression in which a clasp connection of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention is set.

[0050] The design unit (120) can set the clasp connection by considering the positions of the teeth and the buccal surface in the digital impression. First, the design unit (120) can refine the shapes of the incisal papilla, rugae, and median palatal raphe in the digital impression, and set the insertion direction of the upper fixation device. At this time, in order to maintain the clasp, the insertion direction can be set to one or two depending on the shape of the most posterior tooth.

[0051] Referring to FIG. 2, the design portion (120) can set the connection of the clasp so as to connect from a region on the lingual side of the distal surface of the most posterior tooth to a region on the buccal surface. Specifically, the design portion (120) can set the clasp so as to connect from a point 1 / 3 of the lingual side of the distal surface of the most posterior tooth to a point 1 / 2 of the buccal surface.

[0052] FIG. 3 is a drawing showing an example of a digital impression with an offset applied to a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0053] The output setting unit (130) can apply an offset to a digital impression in which a clasp connection is set and set a thickness to generate an output file. Referring to FIG. 3, the output setting unit (130) can apply an offset of a preset size to the digital impression. For example, the output setting unit (130) can apply an offset of 0.04 mm to an oral scan file in which a clasp is set by the design unit (120), i.e., a digital impression. In addition, the output setting unit (130) can generate a new file, i.e., an output file, separated from the digital impression after applying the offset. FIG. 3 illustrates an output file generated after applying the offset.

[0054] FIG. 4 is a drawing showing an example of an output file indicating the thickness setting and occlusal surface of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0055] Referring to FIG. 4, the output setting unit (130) can generate the output file by applying a thickness of a preset size. For example, the output setting unit (130) can set the thickness of the digital impression to 1.3 mm.

[0056] FIG. 5 is a drawing illustrating an example of reinforcing the clasp thickness of a manufacturing device for a customized 3D printing fixation device according to one embodiment of the present invention.

[0057] Referring to Fig. 5, the output setting unit (130) can generate an output file by reinforcing the thickness of the short clasp located at both ends of the clasp. Here, the short clasp refers to a clasp that is mounted on the most posterior tooth and has a shortened length due to the patient's foreign body sensation, while the retention portion refers to a part designed to be mounted on the tooth undercut area. Since the short clasp is weaker than a metal partial denture, it is required to reinforce the strength with thickness to prevent breakage that may occur during attachment and removal.

[0058] Specifically, the output setting unit (130) can reinforce the relief of oral tissue and the thickness of the short clasp to prevent compression of nerves and blood vessels due to the prosthesis in the case of the incisal papilla. In addition, the output setting unit (130) can perform relief for cushioning in the case of the midpalatal suture when the tissue is thin. This is to form a device with the same thickness of the clasp and plate, and then reinforce the clasp and the connecting part to prevent breakage.

[0059] The thickness of the reinforced short clasp may be, for example, 1.4 mm. While not limited to the above thickness, the above thickness is a thickness derived through multiple experiments to ensure the durability of the short clasp while minimizing any foreign body sensation felt by the user. The thickness may be reduced by polishing during the manufacturing process of the upper fixation device. Furthermore, the thickness of the short clasp may be reinforced to compensate for the reduced thickness due to polishing, in addition to the weak tissue compression of the upper fixation device.

[0060] FIG. 6 is a drawing showing an example of an output file of a device for manufacturing a customized 3D printing fixing device according to one embodiment of the present invention, and FIG. 7 is a drawing showing an example of a resin profile setting of a device for manufacturing a customized 3D printing fixing device according to one embodiment of the present invention.

[0061] Fig. 6 shows an example of a designed fixing device. The printing unit (140) can output the fixing device based on the output file.

[0062] When the design of the fixing device is completed by the design unit (120) and the output setting unit (130), the output setting unit (130) can extract the design as an output file. At this time, the output file can have an STL format used for 3D printing. The printing unit (140) can output the fixing device by 3D printing. Referring to FIG. 7, the printing unit (140) can perform 3D printing based on a profile that outputs a resin material. In addition, the setting values ​​can vary depending on the 3D printing.

[0063] 3D printing is a cutting-edge technology that allows for the rapid and precise creation of objects using materials ranging from plastic to metal. It is currently being applied in various dental clinics. In the field of prosthodontics, it is used for temporary or final prosthetics, and in orthodontics, it can be used to create customized orthodontic brackets and occlusal devices for temporomandibular joint disorders.

[0064] In the field of oral and maxillofacial surgery to which the present invention can be applied, it can be utilized in the production of guide devices during implant surgery. According to an embodiment of the present invention, a manufacturing device (100) for a customized 3D printed upper fixation device can be manufactured more simply for both patients and doctors by omitting the impression taking process required for the production of existing devices using oral scanning. In addition, by manufacturing a patient-tailored upper fixation device, convenience in daily life can be improved compared to the past, and it can also contribute to the regeneration of the palatal donor area and reduction of patient pain.

[0065] The 3D-printed upper fixation device of the present invention can be manufactured based on a material polymerized with a light-cured composite resin. While some resins are suitable for temporary use in the oral cavity, such as for impression taking, few are suitable for long-term, daily use after surgery. The resin used to manufacture the upper fixation device is a product used to make removable retainers after orthodontic treatment. It is non-hazardous even when worn for long periods of time and has passed the Ministry of Food and Drug Safety's Class 2 human hazard classification.

[0066] FIG. 8 is a drawing showing an example of a sliced ​​output file of a manufacturing device for a customized 3D printing fixing device according to one embodiment of the present invention.

[0067] Referring to FIG. 8, the printing unit (140) can slice an output file and transmit it to a 3D printer to output a fixing device through 3D printing.

[0068] FIGS. 9 to 11 are drawings showing examples of 3D printed fixing devices of a manufacturing device for a customized 3D printing fixing device according to one embodiment of the present invention.

[0069] Figure 9 is a drawing illustrating a phase fixation device output based on a sliced ​​output file. Figure 10 is a drawing illustrating a 3D printed phase fixation device after being washed with isopropyl alcohol. Afterwards, the printed phase fixation device is cured in a curing machine for 15 minutes after being washed, and the phase fixation device can be applied to a thin resin layer and cured for 5 minutes. Figure 11 illustrates a phase fixation device that has been polished with a polishing agent, such as a paper, using a porous motor after curing.

[0070] Hereinafter, the effectiveness and performance of the fixation device will be described through a surgery using the fixation device manufactured using a device for manufacturing a customized 3D printing fixation device according to one embodiment of the present invention.

[0071] FIGS. 12 to 14 are drawings showing the surgical process using a fixation device manufactured through a device for manufacturing a customized 3D printing fixation device according to one embodiment of the present invention.

[0072] This paper describes the surgical and postoperative course of the implantation of a fixed-gap device. Preoperatively, the oral cavity is rinsed with 0.12% chlorhexidine gluconate (Hexamedine solution) for 1 minute. After local anesthesia with lidocaine hydrochloride containing 1:100,000 epinephrine, a free gingival graft is harvested from the palate using a No. 15 blade.

[0073] The donor site from which the gingiva was provided was not sutured, and a suprapubic fixation device was immediately applied. Antibiotics and analgesics were prescribed three times daily for seven days. After surgery, the applied suprapubic fixation device was checked to ensure adequate compression of the donor site and hemostasis.

[0074] A total of six patients underwent surgery. Three of the six patients reported no discomfort in the recipient area immediately after surgery. The mean discomfort score in the recipient area after surgery was 4.5 (SD 3.83) on the day of surgery, 3.33 (SD 3.38) the day after surgery, and 3.6 (SD 3.04) and 0.75 (SD 0.5) one week after surgery. Table 1 below presents the patient information.

[0075]

[0076] Figure 12 shows the immediate postoperative period after the application of the suprapubic fixation device, Figure 13 shows the period after 24 hours, and Figure 14 shows the period after 1 month. Referring to Figures 12 to 14, one day after the surgery, a white membrane is formed at the suprapubic fixation site of the palate as epithelial cells migrate from the base of the margin to the incision site and cover it. After 2 weeks, the tissue matures, and it can be seen that the color and shape become more similar to the surrounding tissue. After 1 month, complete epithelialization is achieved, and it can be seen that the color of the donor site becomes identical to the color of the surrounding tissue.

[0077] FIG. 15 is a drawing illustrating a flow chart of a method for manufacturing a customized 3D printing fixation device according to one embodiment of the present invention.

[0078] The method for manufacturing a customized 3D printing fixing device disclosed in FIG. 15 can be performed by the manufacturing device (100) of the customized 3D printing fixing device described through FIGS. 1 to 14 above. Therefore, even if the content is omitted below, the content described for the manufacturing device (100) of the customized 3D printing fixing device through FIGS. 1 to 14 can be equally applied to FIG. 15.

[0079] In step S110, the scanning unit (110) can collect a digital impression of the oral cavity using an oral scanner. The scanning unit (110) can collect a digital impression that includes an area from the occlusal surface of the posteriormost tooth to the occlusal surface of the molar of the opposite arch. For example, the scanning unit (110) can collect the digital impression using computer-aided design software (Meshmixer, v3.5), but is not limited to the above program.

[0080] Specifically, the posteriormost tooth is the molar, which is located the innermost in the mouth, and the scanning unit (110) can scan the occlusal surface starting from the occlusal surface of the molar, through the incisors, to the molar in the opposite arch. Thereafter, the buccal and palatal surfaces of the teeth can be scanned.

[0081] At this time, the scanning unit (110) can perform multiple scans until it is confirmed that the gingiva on the distal and buccal sides of the last molar are clearly visible to the naked eye. In addition, in the case of the palate, multiple scans can be performed until the vibration line is clearly visible. The scanned image data, i.e., the digital impression, can be saved in an STL (Stereolithography) file format.

[0082] In step S120, the design unit (120) can set the connection of the clasp by considering the positions of the teeth and the buccal surface in the digital impression. First, the design unit (120) can refine the shapes of the incisal papilla, rugae, and median palatal raphe in the digital impression, and set the insertion direction of the upper fixation device. In order to maintain the clasp, the insertion direction can be set to one or two depending on the shape of the posteriormost tooth. The design unit (120) can set the connection of the clasp to connect from an area on the lingual side of the distal surface of the posteriormost tooth to an area on the buccal surface. Specifically, the design unit (120) can set the clasp to connect from 1 / 3 of the lingual point of the distal surface of the posteriormost tooth to 1 / 2 of the buccal point.

[0083] In step S130, the output setting unit (130) can apply an offset to a digital impression in which a clasp connection is set and set a thickness to generate an output file. The output setting unit (130) can apply an offset of a preset size to the digital impression. For example, the output setting unit (130) can apply an offset of 0.04 mm to the oral scan file in which the clasp is set by the design unit (120), i.e., the digital impression. In addition, the output setting unit (130) can generate a new file separated from the digital impression, i.e., an output file, after applying the offset. Fig. 3 shows an output file generated after applying the offset.

[0084] The output setting unit (130) can generate the output file by applying a preset thickness. For example, the output setting unit (130) can set the thickness of the digital impression to 1.3 mm. In addition, the output setting unit (130) can generate the output file by reinforcing the thickness of the short clasp located at both ends of the clasp.

[0085] In step S140, the printing unit (140) can output the fixing device based on the output file. When the design of the fixing device is completed by the design unit (120) and the output setting unit (130), the output setting unit (130) can extract the design as an output file. At this time, the output file can have an STL format used in 3D printing. The printing unit (140) can output the fixing device through 3D printing.

[0086] According to an embodiment of the present invention, a method for manufacturing a customized 3D printing fixation device may be implemented in the form of program commands that can be executed through various computer means and recorded on a computer-readable medium. The computer-readable medium may include program commands, data files, data structures, etc., either singly or in combination. The program commands recorded on the medium may be those specially designed and configured for the present invention or may be those known and available to those skilled in the art of computer software. Examples of computer-readable recording media include magnetic media such as hard disks, floppy disks, and magnetic tapes, optical media such as CD-ROMs and DVDs, magneto-optical media such as floptical disks, and hardware devices specially configured to store and execute program commands, such as ROMs, RAMs, and flash memories. Examples of program commands include not only machine language codes generated by a compiler, but also high-level language codes that can be executed by a computer using an interpreter, etc. The above hardware devices may be configured to operate as one or more software modules to perform the operations of the present invention, and vice versa.

[0087] The features, structures, effects, etc. described in the above-described embodiments are included in at least one embodiment of the present invention, and are not necessarily limited to only one embodiment. Furthermore, the features, structures, effects, etc. exemplified in each embodiment can be combined or modified and implemented in other embodiments by a person having ordinary skill in the art to which the embodiments belong.

[0088] Accordingly, the contents related to such combinations and modifications should be interpreted as being included within the scope of the present invention. In addition, although the above description focuses on the embodiments, these are merely examples and do not limit the present invention. Those skilled in the art to which the present invention pertains will appreciate that various modifications and applications not illustrated above are possible without departing from the essential characteristics of the present embodiments. For example, each component specifically shown in the embodiments can be modified and implemented. In addition, the differences related to such modifications and applications should be interpreted as being included within the scope of the present invention defined in the appended claims.

[0089] (Explanation of symbols)

[0090] 100: Manufacturing device for a customized 3D printed fixation device

[0091] 110: Scan section

[0092] 120: Design Department

[0093] 130: Output setting section

[0094] 140: Printing Department

Claims

1. In a manufacturing device for a customized 3D printing fixation device, A scanning unit that collects digital impressions of the oral cavity through an intraoral scanner; A design section that sets the connection of the clasp by considering the positions of the teeth and the buccal surface in the above digital impression; An output setting section that generates an output file by applying an offset to a digital impression in which the connection of the above clasp is set and setting a thickness; and A manufacturing device for a customized 3D printing fixing device, comprising a printing unit that outputs a fixing device based on the above output file.

2. In paragraph 1, The above scanning section, A device for manufacturing a customized 3D printed fixed appliance, which collects a digital impression including an area from the occlusal surface of the posteriormost tooth to the occlusal surface of the molar of the opposite arch.

3. In paragraph 1, The above design department, A manufacturing device for a customized 3D printing upper fixed device, which sets the connection of the clasp so as to connect from one area of ​​the distal surface of the posteriormost tooth to one area of ​​the buccal surface.

4. In paragraph 1, The above output setting section, A manufacturing device for a customized 3D printing fixing device, which generates the output file by applying an offset of a preset size to the digital impression and applying a thickness of a preset size.

5. In paragraph 1, The above output setting section, A manufacturing device for a customized 3D printing upper fixation device, which generates the output file by reinforcing the thickness of the short clasp located at both ends of the above clasp.

6. In a method for manufacturing a customized 3D printing fixation device, (a) a step of collecting a digital impression of the oral cavity through an oral scanner; (b) a step in which the design department sets the connection of the clasp by considering the positions of the teeth and the buccal surface in the digital impression; (c) a step of generating an output file by applying an offset to a digital impression in which the connection of the above clasp is set and setting a thickness; and (d) A method for manufacturing a customized 3D printing fixing device, comprising a step of printing a fixing device based on the output file.

7. In paragraph 6, Step (a) above, A method for manufacturing a customized 3D printed fixed appliance, comprising collecting a digital impression including an area from the occlusal surface of the posteriormost tooth to the occlusal surface of the molar of the opposite arch.

8. In paragraph 6, Step (b) above, A method for manufacturing a customized 3D printed upper fixed device, wherein the connection of the clasp is set to connect from an area on the lingual side of the distal surface of the last posterior tooth to an area on the buccal side.

9. In paragraph 6, Step (c) above, A method for manufacturing a customized 3D printing fixation device, comprising: applying an offset of a preset size to the digital impression and applying a thickness of a preset size to generate the output file.

10. In paragraph 6, Step (c) above, A method for manufacturing a customized 3D printing fixation device, wherein the output file is generated by reinforcing the thickness of a short clasp located at both ends of the clasp.

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