Dental Zirconia Ceramic

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 11, 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: K250811 Trade/Device Name: Dental Zirconia Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 17, 2025 Received: March 17, 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} K250811 - 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} K250811 - 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,  Bobak Shirmohammadi -S For Michael E. Adjodha, M.ChE., 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} Dental Zirconia Ceramic Page 8 of 26 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250811 | ? | | Please provide the device trade name(s). | | ? | | Dental Zirconia Ceramic | | | | Please provide your Indications for Use below. | | ? | | Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} 510(k) Summary K250811 510(k) Summary This summary is submitted in accordance with 21 CFR 807.92. 1.0 Submission Sponsor Name: Aidite (Qinhuangdao) Technology Co., Ltd. Address: No.9 Dushan Road, Economic and Technological Development Zone, Qinhuangdao City, China 066004 Hebei P.R.China Contact: Jeffry Ye 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: Feb.28,2025 2.0 Device Information Trade name: Dental Zirconia Ceramic Common name: Dental Zirconia Ceramics Classification name: Porcelain powder for clinical use Production code: EIH Regulation number: 21 CFR 872.6660 Classification: Class II Panel: Dental 3.0 Identification of Predicate Device and Reference Device Predicate Device: 510(k) Number: K222626 Trade/Product Name: Dental Zirconia Ceramic Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd. 1 of page 5 {5} 510(k) Summary ## 4.0 Device Description Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains $\mathrm{ZrO_2 + HfO_2 + Y_2O_3 + Al_2O_3}$ and very small amount of additional inorganic pigments ($\mathrm{Fe_2O_3 + Er_2O_3 + Co_3O_4}$). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. Dental Zirconia Ceramic has 19 models mainly according to the flexural strength (i.e. $\geq 600\mathrm{Mpa}$ and $\geq 800\mathrm{Mpa}$) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems. The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials. ## 5.0 Indication for Use Statement Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. ## 6.0 Non-clinical Test Conclusion Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015/AMD 1:2018 and ISO 13356:2015. According to ISO 6872, the subject device is classified into the following: Type II: All other forms of ceramic products. Class 4: Monolithic ceramic for prostheses involving partially or fully covered substructure Class 5: Monolithic ceramic for prostheses involving partially or fully covered substructure for four or more units. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used. ## 7.0 Technological Characteristics {6} 510(k) Summary ## Principle of Operation There is no change in the principle of operation as part of this submission from the previous clearance under K222626. The module still utilizes the same principles of operation for Dental Zirconia Ceramic governed by the following principles: The proposed device is composed of yttria-stabilized zirconia, it has good physical properties, stable chemical properties and good biocompatibilities, and it's suitable to prepare the dental restorations. When preparing the restoration, the patient's dental model is obtained by the doctor. Based on the desired shape of the restoration, the zirconia block is processed using a proper milling machine. ## 8.0 Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device The subject device, Dental Zirconia Ceramic (Model: Multilayer-3D, UTC, UTM, Multilayer3D pro, SHTPC, SHTPM, SHT-Plus, HT, ST, SHT, AT, COLOR, ST-COLOR, Multilayer, Multilayer-3T, MC, FC, GC, EC) and the predicate device -Dental Zirconia Ceramic (Model: Multilayer-3D, UTC, UTM, Multilayer3D pro, SHTPC, SHTPM), have the following key similarities: - Both devices have the same intended use - Both devices are indicated for the same patient population - Both devices have the same principle of operation and mechanism of action The modifications outlined in this subject device do not raise different questions of safety or effectiveness as demonstrated by performance testing using the same methods based on the FDA-recognized standard ISO 6872 that were utilized for the predicate device. Furthermore, these changes (1) do not affect the intended use or (2) alter the fundamental scientific technology of the device. The modified devices retain the same core technological characteristics as the predicate device. ## 9.0 Summary of Clinical Test Clinical testing was not required for this submission. ## 10.0 Technological Characteristics and Substantial Equivalence The following table shows similarities and differences of use, design, and material between our device and the predicate devices. {7} 510(k) Summary Table1 General Device Characteristics Comparison Table | Item | Subject Device | Predicate device | Remark | | --- | --- | --- | --- | | 510(k) No. | K250811 | K222626 | | | Product Name | Dental Zirconia Ceramic | Dental Zirconia Ceramic | -- | | Product Code | EIH | EIH | Same | | Regulation No. | 872.6660 | 872.6660 | Same | | Class | II | II | Same | | Intended Use/Indication for Use | Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. | Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. | Same | | Prescription Use | Yes | Yes | Same | | Class (per ISO 6872:2015) | Class 4: Multilayer-3D, UTC, UTM, AT, Multilayer. Class 5: Multilayer-3D pro, SHTPC, SHTPM, SHT-Plus, HT, ST, SHT, COLOR, ST-COLOR, Multilayer-3T, MC, FC, GC, EC. | Class 4: Multilayer-3D, UTC, UTM, Class 5: Multilayer-3D pro, SHTPC, SHTPM | Different* | | Composition | Based on yttria-stabilized zirconia | Based on yttria-stabilized zirconia | Same | | Color | Various Color | Various Color | Same | | Intended User | Professional dental technicians | Professional dental technicians | Same | | Dimension | Various | Various | Same | | Single Use | Yes | Yes | Same | | Sterile | Non-sterile | Non-sterile | Same | | Physical Properties | Conform to ISO 6872 | Conform to ISO 6872 | Same | | Biocompatibility | Comply with ISO 7405:2018 ,ISO 10993-1:2018, FDA Guidance | Comply with ISO 7405:2018 ,ISO 10993-1:2018, FDA Guidance | Same | 4 of page 5 {8} 510(k) Summary Analysis*: The subject device is same to the predicate device in terms of indications for use, design, material and processing. The subject device is different from the predicate device in the following: 1) Add a new model " SHT-Plus, HT, ST, SHT, COLOR, ST-COLOR, Multilayer-3T, MC, FC, GC, EC, AT and Multilayer " to the predicate device. The components of each model and each registered color number are basically the same, only the content of each component is slightly different. Physical and mechanical property of the new model is performed per ISO 6872. Both the subject device and the predicate device have same physical/mechanical properties that met the requirements of ISO 6872. ## 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