LuxCreo Flexible Partial Denture Resin

{0} FDA U.S. FOOD & DRUG ADMINISTRATION November 25, 2025 LuxCreo Inc. Tao Feng VP of Legal 350 W. Ontario Street, Suite 700 Chicago, Illinois 60654 Re: K253365 Trade/Device Name: LuxCreo Flexible Partial Denture Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: September 29, 2025 Received: September 30, 2025 Dear Tao Feng: 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} K253365 - Tao Feng 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} K253365 - Tao Feng 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) K253365 | | | Device Name LuxCreo Flexible Partial Denture Resin | | | Indications for Use (Describe) LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics. LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant. | | | 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} X LuxCreo K253365 File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25th, 2025 # Section 20-2 510(k) Summary 1. 510(k) Number TBD 2. Date Prepared November 25th, 2025 3. Submitter LuxCreo Inc. 350 W. Ontario Street Suite 700, Chicago, IL 60654 Registration Number: 3016237718 FEI Number: 3016237718 Tel: +1 650-336-0888 4. Contact Person Tao Feng Title: VP of Legal Telephone Number: 732-301-4246 Email: tao.feng@luxcreo.com 5. Device 5.1 Device information Device Name: LuxCreo Flexible Partial Denture Resin Model: Clear Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing Regulation Description: Denture relining, repairing, or rebasing resin Regulation Number: 21 CFR 872.3760 Device Class: Class II Product Code: EBI Review Panel: Dental 5.2 Use of Device | Question | Yes | No | | --- | --- | --- | | Is the device intended for prescription use (21 CFR 801 Subpart D)? | ☑ | ☐ | | Is the device intended for over-the-counter use (21 CFR 807 Subpart C)? | ☐ | ☑ | {5} X LuxCreo File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25^{\text{th}} , 2025 | Question | Yes | No | | --- | --- | --- | | Does the device contain components derived from a tissue or other biologic source? | | ✓ | | Is the device provided sterile? | | ✓ | | Is the device intended for single use? | ✓ | | | Is the device a reprocessed single use device? | | ✓ | | If yes, does this device type require reprocessed validation data? | | ✓ | | Does the device contain a drug? | | ✓ | | Does the device contain a biologic? | | ✓ | | Does the device use software? | | ✓ | | Does the submission include clinical information? | | ✓ | | Is the device implanted? | | ✓ | # 5.3 Design LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. To accomplish this three-dimensional fabrication, a 3D printer, based on a 3D stereolithographic drawing, prints the pre-determined shape of each dental appliance. 3D Printing uses specialty liquid resins, which when combined with UV (385~405nm) and/or thermal treatment, allows the fabricated part to achieve mechanical properties similar to thermoplastics and excellent biological safety results. LuxCreo Flexible Partial Denture Resin is designed to be used in a system with components of scanner, design fabrication software, validated 3D Printer, cleaning system, and post-curing unit. These components are used together during the additive manufacturing of partial denture bases. Partial denture bases are constructed using LuxCreo Flexible Partial Denture Resin in accordance to the following steps: 1) Design: Patient's bite and dentition is digitally reproduced via intra-oral scan. The quality of the scan impacts the quality and fitment of the resulting device, and is the responsibility of an appropriately trained and qualified practitioner. A dental design service or dental CAD software (e.g. Exocad PartialCAD and LuxDesign) can be used to design dental models in according to treatment plan. The dental model files are imported into dental CAD software (e.g. Exocad PartialCAD and LuxDesign) to generate flexible partial denture base model files. {6} X LuxCreo File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25th, 2025 2) Printing: The flexible partial denture base model files are imported into a slicing software (e.g. LuxFlow) to render the CAD model 3D printable. The CAD model is then sent to an appropriate 3D Printer (e.g. a LuxCreo printer such as iLux Pro Dental and fastprint.io). The 3D printer constructs the partial denture bases out of LuxCreo Flexible Partial Denture Resin. 3) Post-processing: After printing, the printed partial denture bases are subjected to a post-processing treatment that includes cleaning excess resin from the printed part, subjecting the part to additional UV and/or thermal treatment, and finishing the part via support removal and/or any buffing or polishing steps that a dental health professional deems appropriate for aesthetic and functional purposes. Dental professionals can then attach the teeth to the finished flexible denture base using FDA-cleared dental materials, such as approved teeth and adhesive, to construct the partial denture. ## 5.4 Labeling We provide the labeling for the subject device in submission, including the following elements: - Manufacturer Information - Intended Use - Instructions for Clinician Use - Warnings - Product feature and technical parameter - Cleaning instruction ## 5.5 Sterilization There is no sterilization in this 510(k) submission. ## 5.6 Software N/A ## 6. Intended Use ### 6.1 Intended Use LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics. ### 6.2 Indications LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial {7} X LuxCreo File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25th, 2025 dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant. ## 7. Predicate and Reference Device ### 7.1 Primary Predicate Device: Primary Predicate Device Name: Apex Flex Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing Regulation Description: Denture relining, repairing, or rebasing resin. Regulation Number: 21 CFR 872.3760 Device Class: Class II Product Code: EBI 510(k) Number: K250617 510(k) Submitter: SprintRay Inc. Review Panel: Dental ### 7.2 Secondary Predicate Device: Primary Predicate Device Name: FP3D Device Classification Name: Resin, Denture, Relining, Repairing, Rebasing Regulation Description: Denture relining, repairing, or rebasing resin. Regulation Number: 21 CFR 872.3760 Device Class: Class II Product Code: EBI 510(k) Number: K250489 510(k) Submitter: Keystone Industries Review Panel: Dental ### 7.3 Reference Device: Reference Device Name: LuxCreo Clear Aligner System Device Classification Name: Aligner, Sequential Regulation Description: Orthodontic plastic bracket. Regulation Number: 21 CFR 872.5470 Device Class: Class II Product Code: NXC 510(k) Number: K250343 510(k) Submitter: LuxCreo Inc. Review Panel: Dental ## 8. Device Description {8} X LuxCreo File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25th, 2025 LuxCreo Flexible Partial Denture (FPD) Resin is a state of the art resin engineered specifically for the 3D Printing of digitally designed flexible partial denture bases. The FPD resin utilizes LuxCreo's Digital Polishing platform to deliver clear, accurate, and biocompatible partial dentures in a single session with minimal need for finishing. # 9. Comparison of Technological Characteristics with Predicate Devices Please refer to Section 9 Substantial Equivalence Analysis for details. # 10. Comparison of composition and Manufacturing Process with Reference Device Please refer to Section 9 Substantial Equivalence Analysis for details. # 11. Testing Summary | No. | Standard | Test Summary | Name of the Testing Lab/Qualification | Conformity Assessment | Report Name | | --- | --- | --- | --- | --- | --- | | 1 | EN ISO 10993-5:2009 | In Vitro Cytotoxicity Test-1. qualitative analysis 2. MTT method | Guangdong Neway Quality Technology Service Co. Ltd. /Registration No. CNAS L9783 | No cytotoxicity | In Vitro Cytotoxicity Test_WT24011077-11_ | | 2 | EN ISO 10993-10:2021 | Skin Sensitization Test-Guinea Pig maximization test (Saline and Cottonseed Oil extract) | | No delayed hypersensitivity | Skin Sensitization Test_WT24011077-13 | | 3 | EN ISO 10993-23:2021 | Oral Mucosa Irritation Test (Saline and Cottonseed Oil extract) | | No oral mucosa irritation | Oral Mucosa Irritation Test_WT24011077-14 | {9} X LuxCreo File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25th, 2025 | 4 | EN ISO 10993-11:2017 | Acute System Toxicity Test (Saline and Cottonseed Oil extract) | | No acute systemic toxicity | Acute Systemic Toxicity Test Report_WT24011077-12 | | --- | --- | --- | --- | --- | --- | | 5 | EN ISO 10993-11:2017 | Subacute Systemic Toxicity Test (Saline and Cottonseed Oil extract) | | No sub-acute | Subacute Systemic Toxicity Test_WT24011077-15 | | | | | | systemic toxicity | | | 6 | EN ISO 10993-11:2017 | Subchronic System Toxicity Test (Saline and Sesame Oil extract, 90 days) | | No subchronic | Subchronic Systemic Toxicity Test_WT24011077-16 | | | | | | systemic toxicity | | | 7 | EN ISO 10993-3:2014 | Genotoxicity Test-1. Bacterial reverse mutation assay (0.9% sodium chloride injection and dimethylsulfoxide extract)2. In vitro mammalian chromosome aberration test (serum-free RPMI 1640 medium and dimethylsulfoxide extract) | | No genotoxicity | 1. Bacterial reverse mutation assay_WT24011077-19;2. In Vitro Mammalian Chromosome Aberration Test_WT24011077-20 | {10} X LuxCreo File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25th, 2025 | 8 | EN ISO 10993-6:2016 | Impantation Test (subcutaneous implant, 13 weeks) | | No local effects | Tests for Local Effects after Implantation_WT240110 77-17 | | --- | --- | --- | --- | --- | --- | | 9 | ISO 10993-18: 2020 | Chemical Characterization | Centre Testing International Corporation Pinchuang (Shanghai) Co., Ltd. | Pass | Chemical Characterization Report_EL-REP-060.01.E | | 10 | ISO 10993-17: 2023 | Toxicological Risk Assessment | CTI Biotechnology (Suzhou) Co. Ltd. | | Toxicological Risk Assessment Report_Assignment:25 01182 | | 11 | ISO 20795-1:2013 | Performance Test | Ningbo Sezen Technology Co., Ltd. | Complied with Technical Specifications | Section 16-1 FPD_Performance Test Report | | 12 | ISO 20795-1:2013 | Flexural Modulus and Flexural Strength Tests | Gold Standard Test (Guangdong) Co., Ltd. | Complied with Technical Specifications | Section 16-2 Performance Test Performance Test Report (Report No.: GW250808017 ) | | 13 | ASTM D638-2014 | Elongation at Break Test | Ningbo Sezen Technology Co., Ltd. | Complied with Technical Specifications | Section 16-1 FPD_Performance Test Report | ## 12. Clinical Data The nonclinical bench testing conducted in accordance with FDA-recognized consensus standards (ISO 20795-1 for denture base polymers) demonstrated that the subject device meets all applicable performance criteria for strength, durability, water resistance, and residual monomer content. Biocompatibility testing performed in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 7405 confirmed that the device is non-cytotoxic, non-sensitizing, non-irritating, and does not pose systemic or genetic toxicity risks, establishing an acceptable biological safety profile for long-term mucosal contact. No clinical testing was required because the nonclinical evidence and comparison to legally marketed predicate devices with the same intended use and technological characteristics were sufficient to establish substantial equivalence. Taken together, the results demonstrate that the subject device is as safe, as effective, and performs as well as or better than the 7 / 8 {11} X LuxCreo File No.: LC-FPD-FDA-Section 20-2 Version: A/1 Date: November 25th, 2025 identified predicate devices. ## 13. Substantial Equivalence Conclusion Based upon the information presented, in terms of safety and effectiveness, the subject device is essentially equivalent to predicate devices. 8 / 8