Glass Ceramics

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym. February 10, 2023 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, Street, Haidian District Beijing, Beijing 100080 CHINA Re: K222513 Trade/Device Name: Glass Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 9, 2022 Received: December 12, 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 mediation-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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K222513 Device Name Glass Ceramics Indications for Use (Describe) Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) #### 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # K222513 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. #### 1. Date Summary Prepared: Feb. 2, 2023 #### 2. Contact details #### 2.1 Applicant information: | Name | Yilink (Tianjin) Biotechnology Co., Ltd. | |---------------------------|---------------------------------------------------------------------------------| | Address | No 9 Kaituo Road, Balitai Town, Jinnan District, Tianjin City,<br>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: Glass Ceramics Common name: Dental Glass Ceramics 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 | | Aidite (Qinhuangdao)<br>Technology Co., Ltd. | Dental Glass Ceramics Blocks | K192231 | 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 Glass Ceramics contains glass ceramic blocks for dental use. The main ingredients of the product include Silica: 55%~65%: Lithium oxide: 12%~25%: Alumina: 2%~12%; Potassium oxide: 2%~14%; Other oxides: 0%~10%. Through the digital scanning of teeth or tooth mold, 3D data of tooth mold can be obtained. According to this data, CAD design can be carried out to design porcelain block processing model. Then, a CNC machine tool was used to manufacture the all-porcelain denture crown by CAM according to the porcelain block processing model. After air sintering or vacuum sintering, the all-porcelain denture was made to achieve the strength and aesthetic effect required by clinical use. #### 6. Indications for Use Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system. # 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 Glass Ceramics 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: Table 4: Technological Characteristics Comparison Table {5}------------------------------------------------ | Technological<br>Characteristics | Subject device | Primary predicate | | | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------| | | Glass Ceramics | Dental Glass Ceramics Blocks<br>K192231 | | | | Product code | EIH | EIH | | | | Indications for Use | Glass Ceramicss are indicated for<br>fabricating all-ceramic restorations such<br>as crown, bridge, inlay, veneer. | Dental Glass Ceramics Blocks are indicated<br>for fabricating all-ceramic restorations such<br>as veneers, inlay/onlay, partial crowns,<br>anterior crowns, posterior crowns, using the<br>hot press technique or CAD/CAM system. | | | | Composition | SiO2, Li2O, K2O, Al2O3 and other oxides | SiO2, Li2O, K2O, Al2O3 and other oxides | | | | Pressing at Dental<br>lab | Hot Press (Up. Press Series)<br>CAD/CAM (Up.CAD Series) | Hot Press (Up. Press Series)<br>CAD/CAM (Up.CAD Series) | | | | Dimension | Various | Various | | | | Single use | Yes | Yes | | | | Available Color | Various | Various | | | | Sterile | Non-sterile | Non-sterile | | | | | 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. | | | | | Physical Properties | Item | Testing criteria | Subject<br>device/HT | Primary<br>predicate/HT | | | Flexural strength | ≥100MPa | 356.7 | 348.9 | | | Chemical solubility | ≤100µg·cm-2 | 25.3 | 28.5 | | | Coefficient of<br>thermal expansion | $( 11±0.5 ) ×10-6K-1(0-500°C )$ | 10.8 | 10.8 | | | Glass transition<br>temperature | HT/MT: (520±20) °C<br>LT: (510±20) °C | 510 | 510 | # 9. Summary of Biocompatibility The new device, Glass Ceramicss, 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, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity. # 10. Clinical Performance Data Not applicable. Clinical performance testing has not been performed for the subject device. # 11. Non-clinical Testing Bench testing was performed per ISO 6872:2015 and internal procedure to ensure that the Glass Ceramics {6}------------------------------------------------ met the specifications. All tests were verified to meet the acceptance criteria. #### 12. 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.