Additively Manufactured Aligner Resin

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 27, 2025 Aidite (Qinhuangdao) Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lu Jiazui Rd., Pudong Shanghai, 200120 CHINA Re: K251415 Trade/Device Name: Additively Manufactured Aligner Resin Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC, MQC Dated: July 29, 2025 Received: July 30, 2025 Dear Boyle Wang: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251415 - Boyle Wang Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K251415 - Boyle Wang Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, MICHAEL E. ADJODHA -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251415 | | | Device Name Additively Manufactured Aligner Resin | | | Indications for Use (Describe) This product is suitable for making invisible orthodontic appliances by additive manufacturing (light curing 3D printing) process. The orthodontic appliance is designed for orthodontic treatment. It uses continuous gentle force to adjust tooth position, correct malocclusion, and maintain the results of completed orthodontic treatment. It can also be used for printing splints and night guards. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} 510(k) Summary # 510(k) Summary # K251415 This summary is submitted in accordance with 21 CFR 807.92. ## 1.0 Submission Sponsor Name: Aidite (Qinhuangdao) Technology Co., Ltd. Address 1: No.9 Dushan Road, Economic and Technological Development Zone, Qinhuangdao City, 066004 Hebei P.R.China Address 2: No. 56 Tianchi Road, Economic and Technological Development Zone, Qinhuangdao City, 066004 Hebei P.R. China Contact: Mr. Ye Zhanfu Tel: +86 335 8587898 Fax: +86 335 8587198 ## Designated Submission Correspondent Contact: Mr. Boyle Wang Address: Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lu Jiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: info@truthful.com.cn Date of Preparation: Jul.29th, 2025 ## 2.0 Device Information Trade name: Additively Manufactured Aligner Resin Common name: Additive Manufacturing (Light Curing) Orthodontie Resin Model: DPAS-C Classification name: Material, Tooth Shade, Resin Production code: NXC,MQC Regulation number: 21 CFR 872.5470 Classification: Class II Panel: Dental ## 3.0 Identification of Predicate Device and Reference Device Predicate Device 1: {5} 510(k) Summary 510(k) Number: K212680 Trade/Product Name: LuxCreo Clear Aligner System Manufacturer: LUXCREO INC. Predicate Device 2: 510(k) Number: K221022 Trade/Product Name: NextDent Ortho Flex Manufacturer: Vertex-Dental BV ## 4.0 Device Description Additively Manufactured Aligner Resin is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state. Additively Manufactured Aligner Resin is a light-curing resin used to print orthodontic appliances. The resin is a light yellow transparent liquid. The appliance printed by a 3D printer is de-supported, cleaned and post-cured to obtain an orthodontic appliance that can correct the patient's malocclusion. This product is a light-curing 3D printing resin composed of acrylate resin oligomers and acrylate monomers as well as initiators and additives. Additive manufacturing (light cured) orthodontic resin is a light cured acrylic resin commonly used in the manufacture of orthodontic appliances. The resin is stored in a black HDPE bottle according to the weight of the resin liquid. The color of the resin is colorless or yellowish liquid, polymerized by UV light at 385 nm or 405 nm. ## 5.0 Indication for Use Statement This product is suitable for making invisible orthodontic appliance by additive manufacturing process (light curing 3D printing process). The orthodontic appliance is designed for orthodontic treatment. It uses continuous gentle force to adjust tooth position, correct malocclusion, and maintain the results of completed orthodontic treatment. It can also be used for printing splint and night guard. ## 6.0 Non-clinical Test Conclusion **Bench Testing:** - The most applicable standard for mechanical characteristics determination of the subject device is FDA-recognized version ISO 20795-2:2013 Dentistry – Base polymers – Part 2: Orthodontic base polymers. Performance testing including Homogeneity, Surface Properties, Forming 2 of page 6 {6} 510(k) Summary Performance, Color, No Porosity, Flexural Strength, Flexural Modulus, Ultimate Flexural Strength, Water Solubility and Water Sorption. All test results of above items were similar to that of the predicate device that meet the requirements of ISO 20795-2:2013. The performance characteristics of the subject device are comparable to those of the predicate device for this particular indication and raise no new or different questions of safety and effectiveness. Therefore, the subject device and the predicate device are substantially equivalent in physical properties. - Printers Validation: Different printers are validated for processing (3D printing) using the candidate device. Additional printers post-510(k) clearance will be added to the labelling by means of the Quality Systems and within the validation plan presented in this 510(k). ## Biocompatibility Testing: The nature of body contact of materials used in the design of the Additively Manufactured Aligner Resin were classified as being Surface Devices in contact with mucosal membrane with a permanent contact duration of >30 days, repeated use. The biocompatibility testing was performed according to FDA currently-recognized versions of biocompatibility consensus standards ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and ISO 7405:2018 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry. The following biological safety aspects have been addressed: - Cytotoxicity – ISO 10993-5 - Sensitization – ISO 10993-10 - Irritation – ISO 10993-23 - Acute Systemic Toxicity – ISO 10993-11 - Subchronic Systemic Toxicity – ISO 10993-11 - Genotoxicity – ISO 10993-3 Sterility and Shelf-Life Testing: The device is provided non-sterile. Based on shelf-life testing, the Additively Manufactured Aligner Resin has an unopened shelf life of 2 years. Once opened, the resin should be used within 60 days and must be protected from light exposure. ## 7.0 Technological Characteristics and Substantial Equivalence The following table shows similarities and differences of use, design, and material between our device and the predicate devices. Table 1- Comparison of Technology Characteristics 3 of page 6 {7} 510(k) Summary | Item | Subject Device | | Predicate Device 1 | Predicate Device 2 | | Remark | | --- | --- | --- | --- | --- | --- | --- | | 510(k) No. | K251415 | | K212680 | K221022 | | -- | | Product Name | Additively Manufactured Aligner Resin | | LuxCreo Clear Aligner System | NextDent Ortho Flex | | -- | | Product Code | NXC | MQC | NXC | MQC | KMY | Same | | Regulation No. | 21 CFR 872.5470 | NA | 21 CFR 872.5470 | NA | 21 CFR 872.5525 | Same | | Class | Class II | | Class II | Unclassified (pre amendment) | Class 1 | Same | | Intended Use/Indication for Use | This product is suitable for making invisible orthodontic appliance by additive manufacturing process (light curing 3D printing process). The orthodontic appliance is designed for orthodontic treatment. It uses continuous gentle force to adjust tooth position, correct malocclusion, and maintain the results of completed orthodontic treatment. It can also be used for printing splint and night guard. | | LuxCreo Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The LuxCreo Clear Aligner System repositions teeth by way of continuous gentle force. | NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition. NextDent Ortho Flex is intended exclusively for professional dental work. | | Same* (Analysis 1) | | Mode of Action | Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays | | Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays | Not publiclt available | | Same with Predicate Device 1 | | Method of Use | Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually for 7-10 days, usually no more than 15 days prior to using the next sequential aligner tray | | Each preformed plastic tray is worn by the patient as prescribed by the dental practitioner, usually a few weeks prior to using the next sequential aligner tray | Not publiclt available | | Same with Predicate Device 1 | | Prescription | Rx | | Rx | Rx | | Same | 4 of page 6 {8} 510(k) Summary | Use | | | | | | --- | --- | --- | --- | --- | | Duration of Use | Each set of aligners can be worn for approximately 2 weeks of 20-22 hours of wear per day or according to doctor’s prescription. | 20-22 hours/day | Not publiclt available | Same with Predicate Device 1 | | Method of Manufacturing | Light-cured 3D printing | Light-cured 3D printing | Light-cured 3D printing | Same | | Software Used for Ordering Workflow | Yes | Yes | Yes | Same | | Application | Removable | Removable | Removable | Same | | Materials | Light-cured polyurethane resin | Light-cured polyurethane resin | acrylate-based UV light cure resin | Similar | | Shelf-Life | 24 months | Six-month | 18 months | Different (Analysis 2) | | Performance Testing | Per ISO 20795-2:2013 | ISO 20795-2:2013 | ISO 20795-2:2013 | Same | | Flexural Modulus | Average 877.49 MPa | 804 ± 64 MPa | Not publiclt available | Different (Analysis 3) | | Ultimate Flexural Strength | Average 39.72 MPa | 23.6 ± 1.9 MPa | Not publiclt available | | | Water Solubility | Average 3.05μg/mm³ | 3.668±1.0748 μg/mm³ | Not publiclt available | | | Water Sorption | Average 29.94μg/mm³ | 19.952±6.6719 μg/mm³ | Not publiclt available | | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | Biocompatibility | ISO 10993-5 In vitro Cytotoxicity ISO 10993-10 Oral Mucosa Irritation ISO 10993-23 Skin Irritation ISO 10993-11 Acute Systemic Toxicity ISO 10993-11 Subacute Systemic Toxicity ISO 10993-3 Genotoxicity | ISO 10993-5 In vitro Cytotoxicity ISO 10993-10 Oral Mucosa Irritation Pyrogen ISO 10993-10 Skin Irritation in Rabbits ISO 10993-10 Skin Sensitization in Guinea Pigs (Maximization Test) ISO 10993-11 Acute Systemic Toxicity | • Cytotoxicity • Sensitization • Irritation or intra cutaneous reactivity • Subacute/sub chronic systemic toxicity • Genotoxicity • Chemical characterization | Same | 5 of page 6 {9} 510(k) Summary ## Analysis*: 1) The Indication for Use of the subject device, Additively Manufactured Aligner Resin, is consistent with the combined indications of the identified predicate devices. The subject device incorporates the orthodontic therapeutic purpose of Predicate Device 1 and the dental splint manufacturing capability of Predicate Device 2. There are no new indications introduced, and the overall intended use remains consistent with legally marketed predicate devices, supporting substantial equivalence. 2) The difference in shelf life does not impact their substantial equivalence. The shelf-life validation report of the subject device demonstrates the stability of the products' performance over time, ensuring their reliability and safety during their respective shelf lives. 3) There are measurable differences among the Flexural Modulus and Ultimate Flexural Strength. The Flexural Modulus and Ultimate Flexural Strength of the subject device is better than the predicate device because the average values of the subject device were statistically significantly higher than that of the predicate device. Water Solubility and Water Sorption values of the subject device and the predicate devices were slight different, all tested materials conform to the requirements of ISO 20795-2:2013, the differences observed are not expected to adversely affect the safety or effectiveness of the subject device. Therefore, the subject device is considered substantially equivalent to the predicate devices in terms of performance characteristics. ## 8.0 Summary of Clinical Test Clinical testing was not required for this submission. ## 9.0 Conclusion The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device. 6 of page 6