Zirconia Block

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November 14, 2022 Yilink (Tianjin) Biotechnology Co., Ltd % Jennifer Liu Regulation Affairs Specialist Chenhe Medical Consulting Co., Ltd Room 113 7th Floor, Block B, Building 1, No. A 38 Zhongguancun Street, Haidan District Beijing, Beijing 100080 CHINA Re: K222520 Trade/Device Name: Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 8. 2022 Received: August 19, 2022 Dear Jennifer Liu: 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 (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 located 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}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, M.ChE. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222520 Device Name Zirconia Block Indications for Use (Describe) Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. All blocks are processed by dental laboratories or by dental professionals. | 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. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # K222520 005_510 (k) Summary This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92. #### Date Summary Prepared: Aug. 8, 2022 1. # 2. Contact details # 2.1 Applicant information: | Name | Yilink (Tianjin) Biotechnology Co., Ltd. | |---------------------------|----------------------------------------------------------------| | Address | No 9 Kaituo Road, Balitai Town, Jinnan District, Tianjin City, | | | 300350, China | | Tel: | 0086- 022-88522665 | | Contact person and title: | Yaqiong Zhu, Engineering manager | | E-mail | 1039001641@qq.com | # 2.2 Submission Correspondent | Name | Chenhe Medical Consulting Co., Ltd | |---------------------------|--------------------------------------------------------------------------------------------------------------| | Address | Room 113, 7th Floor, Block B, Building 1, No. A 38,<br>Zhongguancun Street, Haidian District, Beijing, China | | Tel: | 086 633 13774915658 | | Contact person and title: | Jennifer Liu/Regulatory Affairs Manager | | E-mail | Jennifer19862022@163.com | # 3. Device Name Trade name: Zirconia Block Classification name: Powder, Porcelain Regulatory Class: II Product Code: EIH # 4. Predicate Device Information {4}------------------------------------------------ | Table 1: Predicate Device Information | | | | | | |---------------------------------------|--------------------------------------------------------------------|-------------|--------------|-----------|--| | Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate | | | Liaoning Upcera Company<br>Limited | Upcera Dental Zirconia Blank &<br>Dental Zirconia Pre-Shaded Blank | K141724 | EIH | Primary | | This predicate device has not been subject to a design-related recall. No reference devices were used in this submission. # 5. Description of Device Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made. # 6. Indications for Use Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. All blocks are processed by dental laboratories or by dental professionals. # 7. Summary of Physical and Chemical Properties Tests Test standards and methods based on ISO 6872:2015 (Dentistry - Ceramic materials) and internal final inspection standard of Yilink (Tianjin) Biotechnology Co., Ltd.. And the results from testing demonstrate that Zirconia Block is substantially equivalent to the predicate device. # 8. Technological Characteristics All components of the subject device are based upon industry well-known chemistry. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device: {5}------------------------------------------------ | Table 4: Technological Characteristics Comparison Table | | | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | Subject device<br>Zirconia Block | Primary predicate<br>Upcera Dental Zirconia Blank & Dental<br>Zirconia Pre-Shaded Blank<br>K141724 | | Product code | EIH | EIH | | Indications for Use | Zirconia Block is used for dental<br>restorations, such as crown, bridge, inlay,<br>veneer, using CAD/CAM or manual<br>milling machines. All blocks are<br>processed by dental laboratories or by<br>dental professionals. | Upcera Dental Zirconia Blank & Dental<br>Zirconia Pre-Shaded Blank are used for<br>dental restorations using different<br>CAD/CAM or manual machines. All blocks<br>are processed though dental laboratories or<br>dental professionals. | | Composition | ZrO2, Y2O3, HfO2, Al2O3 and other oxides | ZrO2, Y2O3, HfO2, Al2O3 and other oxides | | Pressing at Dental<br>lab | Sintering Press<br>CAD/CAM | Sintering Press<br>CAD/CAM | | Dimension | Various | Various | | Single use | Yes | Yes | | Available Color | Various | Various | | Sterile | Non-sterile | Non-sterile | | Physical Properties | The subject device and the predicate device have substantially equivalent physical<br>property as they all conform to the specifications set by internal final inspection and the<br>test method equal to ISO 6872:2015 | | # 9. Summary of Biocompatibility The new device, Zirconia Blocks, is substantially equivalent to the predicate devices that have been legally marketed for decades and with no clinical adverse events. The formulation of new device does not contain any non-conventional chemicals compared to the legally marketed predicate device. Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Systemic Toxicity, Subchronic Toxicity and Genotoxicity. # 10. Clinical Performance Data Not applicable. Clinical performance testing has not been performed for the subject device. # 11. Conclusions Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate devices affecting neither the general intended use nor substantial equivalence. Yilink (Tianjin) Biotechnology Co., Ltd. concludes that the subject device is substantially equivalent to the predicate devices described herein.