LumiCera

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 21, 2026 Hangzhou SHINING3D Dental Technology Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 7 Giralda Farms, Suite 120a Madison, New Jersey 07940 Re: K260170 Trade/Device Name: LumiCera Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: January 20, 2026 Received: January 20, 2026 Dear Dave Yungvirt: 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. {1} K260170 - Dave Yungvirt 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 {2} K260170 - Dave Yungvirt Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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 (8/23) 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: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K260170 | | | Device Name LumiCera | | | Indications for Use (Describe) LumiCera is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges. | | | 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} K260170 # 510(k) Summary ## I Submitter Submitter Name: Hangzhou SHINING3D Dental Technology Co., Ltd. Establishment Registration Number: 3026312357 Submitter Address: 9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan, Hangzhou, Zhejiang, 311258, China Contact Person: Yuzhuo Wang Title: Regulatory Affairs Specialist Phone: +86 15005173276 Email: wangyuzhuo@shining3d.com Date Prepared: January 16th, 2026 ## II Device Device Name: LumiCera Model: CB200-A1, CB200-A2, CB200-B1, CB200-BL, CB200-C2 Regulation Name: Tooth shade resin material Regulation Number: 21 CFR 872.3690 Regulatory Class: Class II Product Code: EBF Review Panel: Dental ## III Predicate Device Trade/Device Name: FREEPRINT® crown 1 / 10 {5} Regulation Name: Tooth shade resin material Regulation Number: 21 CFR 872.3690 Regulatory Class: Class II Product Code: EBF Submitter Name: DETAX GmbH 510(k) Number: K222877 ## IV Device description The product should be used in combination with SHINING3D printer. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by photoinitiator contained in the resin. The resin is printed in multiple layers automatically, with each layer being subjected to light curing before the addition of the next layer, and then undergoes post-curing in a curing device. The product is intended exclusively for professional dental work. ## V Intended Use /Indications for use LumiCera is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges. ## VI Available model and Specification | Model | Color | | --- | --- | | CB200-A1 | A1 | | CB200-A2 | A2 | | CB200-B1 | B1 | | CB200-BL | 0M2 | | CB200-C2 | C2 | {6} Specification: 0.5 kg/bottle, Nano ## VII Comparison to predicate devices The following table shows comparison and discussion between the subject device and the predicate device. 3 / 10 {7} | Item | Subject device | Predicate device | Remark | | --- | --- | --- | --- | | Product Name | LumiCera | FREEPRINT® crown | -- | | Regulation Name | Tooth shade resin material | Tooth shade resin material | Same | | Product Code | EBF | EBF | Same | | Regulation Number | 21 CFR 872.3690 | 21 CFR 872.3690 | Same | | Regulatory Class | Class II | Class II | Same | {8} | Item | Subject device | Predicate device | Remark | | --- | --- | --- | --- | | Indication for Use /Intended Use | LumiCera material is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges. | FREEPRINT® crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit. | Similar (Analysis 1) | {9} | Item | Subject device | Predicate device | Remark | | --- | --- | --- | --- | | Technology | 3D liquid (light-cured) print resin for dental CAD/CAM | 3D liquid (light-cured) print resin for dental CAD/CAM | Same | | Materials | LumiCera is composed of methacrylate polymer resin with photo initiator, and pigments. | Methacrylate polymer resin with photo initiator, and pigments. | Same | | Materials Shade | Common VITA-shades: A1, A2, B1, BL, C2 | Common VITA-shades: A1, A2, A3, B1, B3, BL, C3, D3 | Similar (Analysis 2) | | Curing Method | UV Light, 365~405 nm w/post curing | Visible light, 385 nm w/post curing | Similar (Analysis 3) | | Equipment | Validated 3D-Printer and post curing devices. | Validated 3D-Printer and post curing devices | Same | | Sterile | Non-sterile | Non-sterile | Same | | Shelf-Life | 2 years | 2 years | Same | {10} | Item | Subject device | Predicate device | Remark | | --- | --- | --- | --- | | Performance Testing | ISO 4049:2019ISO 10477:2020 | ISO 4049:2019ISO 10477:2020 | Same | | Depth of Cure | Hardness of bottom surface ≥70% top surface | Hardness of bottom surface ≥70% top surface | Same | | Surface Finish | Glossy surface after polishing | Glossy surface after polishing | Same | | Flexural Strength | ≥ 100 MPa | ≥ 100 MPa | Same | | Water Sorption | ≤ 40 μg/mm3 | ≤ 40 μg/mm3 | Same | | Water Solubility | ≤ 7.5 μg/mm3 | ≤ 7.5 μg/mm3 | Same | | Biocompatibility Testing | Comply with ISO 10993-1:2018, and ISO 7405:2018 | Comply with ISO 10993-1:2018, and ISO 7405:2018 | Same | {11} VIII Discussion for similarities **Analysis 1. Indication for Use/Intended Use** Both subject devices and predicate devices can be used to manufacture permanent single crowns, permanent inlays and onlays, veneers, and bridges with same manufacturing processes. Predicate devices have a wider range of intended use compared to subject devices. The minor difference does not influence substantial equivalence. **Analysis 2. Materials Shade** The different color due to the composition in the content of pigments. These color variations do not raise new questions of safety or effectiveness, as both devices meet the required performance and biocompatibility standards. Therefore, the differences in color do not impact the substantial equivalence of the subject device to the predicate device. **Analysis 3. Curing Method** The Subject and Predicate devices are both photo-curable polymer resins. Photo-curable polymer resins exhibit similar free radical polymerization efficiency among 365 nm ~405 nm light regions. Slight differences in the curing light wavelength do not influence substantial equivalence. IX Summary of Testing (Performance Data): **Non-Clinical Performance Test Conclusion** **Biocompatibility testing** Based on ISO 10993-1 and ISO 7405, the subject device is categorized as a surface device in contact with mucosal membrane with Long-term contact (>30d). The subject device was evaluated for: 8 / 10 {12} - Cytotoxicity Test - Sensitization Test - Oral Mucosa Irritation Test - Intracutaneous Reactivity Test - Acute Systemic Toxicity Test - Subchronic Systemic Toxicity Test - Implantation Test - Pyrogen Test - Genotoxicity Test ## Bench Testing: Physical and mechanical properties of the subject device were evaluated according to FDA-recognized version ISO 4049 Dentistry - Polymer-based restorative materials and ISO 10477 Dentistry - Polymer-based crown and veneering materials. The test results demonstrated the Subject device meets the property requirements of the referenced standards. Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input. ## Sterility and Shelf-Life Testing: The device is provided non-sterile. From the Shelf-life testing, LumiCera has a shelf life of 2 years. ## Clinical Test Conclusion: No clinical study is included in this submission. 9 / 10 {13} X Conclusion The subject device is as safe and effective as its predicate device. The subject device has similar intended use, and same material, technology and performance characteristics. The minor differences among the subject device and predicate devices have not raised extra safety and performance concerns, based on the relevant tests and evaluations provided in this submission. Performance data confirm that the subject device demonstrates equivalent safety and effectiveness to the predicate device. Thus, LumiCera is substantially equivalent. 10 / 10