Biomic Color Opaque

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 20, 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: K250534 Trade/Device Name: Biomic Color Opaque Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 24, 2025 Received: February 24, 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} K250534 - 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} K250534 - 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 (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) K250534 | | | Device Name Biomic Color Opaque | | | Indications for Use (Describe) Biomic Color Opaque is liquid used for coloring pre-sintered zirconia restorations. It is used for the internal surface of dental zirconia material prosthesis. | | | 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} K250534 - 510(k) Summary # K250534 - 510(k) Summary ## 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: May 16,2025 ## 2.0 Device Information Trade name: Biomic Color Opaque Common name: Pre-Sintered Zirconia Coloring Liquid Classification name: Porcelain Powder For Clinical Use Product code: EIH Regulation number: 21 CFR 872.6660 Classification: Class II Panel: Dental ## 3.0 Identification of Predicate Device 510(k) Number: K232682 Trade/Product Name: Pre-Sintered Zirconia Coloring Liquid Product code: EIH Regulation number: 21 CFR 872.6660 Classification: Class II Manufacturer: Chengdu Besmile Medical Technology Co., Ltd. 1 of page 5 {5} K250534 - 510(k) Summary ## 4.0 Device Description Biomic Color Opaque is a liquid primarily composed of Methylacryloyl propyl trimethoxy silane, deionized water, 1, 3-butanediol, ferric chloride, citric acid, cerium nitrate, erbium nitrate, cobaltous nitrate, manganous acetate, and aluminum nitrate. This product is designed for use on the internal surface of dental zirconia material prostheses. It penetrates tightly with the zirconia surface, forming an extremely thin shade layer that reduces the internal surface permeability of the zirconia material prosthesis. The devices are intended to be used solely by dental technicians for the fabrication of zirconia restorations for individual dental patients. For staining, the zirconia materials must be immersed into the staining solution or brushed with the liquid before sintering at high temperature. The staining solution consists of two components: Type I - a color component (A、B、C、D、W、L、M、R、S、X), and Type II - an OP component, 1:1 collocation is recommended. These components are mixed together for use on the zirconia material to achieve the desired shade. ## 5.0 Indication for Use Statement Biomic Color Opaque is liquid used for coloring pre-sintered zirconia restorations. It is used for the internal surface of dental zirconia material prosthesis. ## 6.0 Non-clinical Test Conclusion **Bench Testing:** - Physical and mechanical properties of the subject device were evaluated according to FDA-recognized version ISO 6872:2015/AMD 1:2018 Dentistry - Ceramic materials. Test items include appearance, uniformity, no foreign matter, flexural strength, chemical solubility and linear expansion coefficient and all tests were verified to meet acceptable criteria. **Biocompatibility Testing:** The nature of body contact of materials used in the design of the Biomic Color Opaque were classified as being Surface Devices in contact with mucosal membrane with a permanent contact duration of >30 days. 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: {6} K250534 - 510(k) Summary - Cytotoxicity – ISO 10993-5 - Sensitization – ISO 10993-10 - Oral Mucosa Irritation – ISO 10993-23 - Acute Systemic Toxicity – ISO 10993-11 - Pyrogen Test – ISO 10993-11 - Subcutaneous Implant Test – ISO 10993-6 - Bacterial Reverse Mutation Test – ISO 10993-3 - TK Gene Mutation Test – ISO 10993-3 - Chemical Characterization Study – ISO 10993-18 Sterility and Shelf-Life Testing: The device is provided non-sterile. From the shelf life testing report, the Biomic Color Opaque has a shelf life of 18 months. ## 7.0 Summary of Clinical Test Clinical testing was not required for this submission. ## 9.0 Technological Characteristics and Substantial Equivalence The following table shows similarities and differences of use, design, and material between the subject and predicate devices. Table 1- Comparison of Technology Characteristics | Item | Subject Device | Predicate Device | Remark | | --- | --- | --- | --- | | 510(k) No. | K250534 | K232676 | -- | | Product Name | Biomic Color Opaque | Pre-Sintered Zirconia Coloring Liquid | -- | | Product Code | EIH | EIH | Same | | Regulation No. | 21 CFR 872.6660 | 21 CFR 872.6660 | Same | | Class | II | II | Same | | Indications for Use | Biomic Color Opaque is liquid used for coloring pre-sintered zirconia restorations. It is used for the internal surface of dental zirconia material prosthesis. | It is only used for coloring Zirconia Denta Ceramics of our company to achieve clinical aesthetic restoration. | Same (Analysis 1) | | Prescription Use | Yes | Yes | Same | | Physical Form | Liquid | Liquid | Similar | {7} K250534 - 510(k) Summary | Materials | Methylacryloyl propyl trimethoxy silane, deionized water, 1, 3-butanediol, ferric chloride, Citric acid, Cerium nitrate, Erbium nitrate, Cobaltous nitrate, Manganous acetate and Aluminum nitrate. | The product is mainly composed of purified water (55%~95%), ferric chloride (0~9%), Erbium Chloride (0~17%), polyethylene glycol(2%~6%), Polydextrose (0.5%~8%), Gluconic acid (1%~2%), Citric acid (0%~1%) and Yttrium chloride (0~12%) | Different (Analysis 2) | | --- | --- | --- | --- | | Operation Principle | Mix Type I and Type II color (1:1 collocation )and brush or immerse zirconia dental ceramics in the mixed Biomic Color Opaque before sintering. | Brush or immerse zirconia dental ceramics with coloring liquid before sintering | Same | | Physicochemical Properties | Complied with the standard ISO 6872 Dentistry – Dental Ceramics --Appearance, --Uniformity, --No Foreign Matter, --Flexural Strength, --Chemical Solubility --Linear Expansion Coefficient | Complied with the standard ISO 6872 Dentistry – Dental Ceramics | Same | | Bottle Size | Various | Various | Same | | Type of Packaging | Liquid container | Liquid container | Same | | Color | A-OP,B-OP,C-OP,D-OP,W-OP,L-OP, M-OP,R-OP,S-OP,X-OP | O1, O2, O3, G1, G2, G3, P1, P2, P3, V1, V2, V3, TO1, TO2, TO3, TO4, BL1, BL2, BL3, BL4, 0M1, 0M2, 0M3. | Different (Analysis 3) | | Categorization by nature of body contact | Surface-contacting medical devices Mucosal membranes | Surface-contacting medical devices Mucosal membranes | Same | | Categorization by duration of contact | Long-term exposure contact time exceeds 30d | Long-term exposure contact time exceeds 30d | Same | | Intended site | Patient's oral cavity | Patient's oral cavity | Same | | Sterile | Non-sterile | Non-sterile | Same | | Biocompatibility | Comply with ISO 10993-1:2018, and ISO 7405:2018 | Comply with ISO 10993-1, ISO 7405:2018 | Same | 4 of page 5 {8} K250534 - 510(k) Summary **Analysis:** The subject device is highly similar to the predicate device in terms of indications for use, design, components and processing. The subject device is different from the predicate device in the following: 1) While the wordings differ, the two descriptions essentially refer to the same intended use of the product, which is the application of liquid for coloring pre-sintered zirconia materials used in dental prostheses. 2) The minor difference between the materials of subject device and the predicate device will not cause any safety issues since the subject device has passed the biocompatibility test. Accordingly, it was concluded that the subject device is substantially equivalent in biocompatibility to the predicate device. 3) The color options refer to different shades or finishes, but do not change the device's function. Also, performance testing and biocompatibility test show the differences in color do not alter the fundamental safety, efficacy, or functional use of the device. **10.0 Conclusion** The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device. 5 of page 5