Glass Ceramic

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 10, 2023 Shenzhen Xiangtong Co.,Ltd. % Ray Wang Gerneral Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA Re: K223194 Trade/Device Name: Glass Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 12, 2022 Received: December 12, 2022 Dear Ray 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 (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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223194 Device Name Glass Ceramic Indications for Use (Describe) Glass Ceramic are indicated for fabricating all-ceramic restorations such as veneers, inlays, onlays, crowns, 2-unit anterior bridges, using the CAD/CAM system. 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." {3}------------------------------------------------ # 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number: - 1. Date of Preparation: 12/21/2022 - 2. Sponsor ## SHENZHEN XIANGTONG CO.,LTD. 2nd Floor, 1st Building, West Area, Honghualing Industrial Park, No.88, North Zhuguang Rd, Nanshan District, Shenzhen, 518055, China. Contact Person: Xue Gong Position: Regulatory Affairs Tel: +86-13760477635 Email: gongx(@xianton.com - 3. Submission Correspondent ## Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com #### 4. Proposed Device Identification Trade Name: Glass Ceramic Common Name: Powder, Porcelain Regulatory Information: Classification: II Product Code: EIH Regulation Number: 21 CFR 872.6660 {4}------------------------------------------------ Regulation Name: Porcelain powder for clinical use Review Panel: Dental Indication For Use Statement: Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system. - ર. Device Description Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system. The Glass Ceramic is composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides, the performance of the Glass Ceramic conforms to ISO 6872: 2015 Dentistry: Ceramic Materials. The Glass Ceramic is disposable device, and provided as non-sterile. - 6. Predicate Device Identification #### Predicate Device: 510(k) Number: K141727 Product Name: Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) Manufacturer: Liaoning Upcera Co., Ltd #### Reference Device: 510(k) Number: K051705 Product Name: IPS E.MAX CAD Manufacturer: Ivoclar Vivadent AG #### 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - A ISO 10993-3: 2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - ♪ ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity {5}------------------------------------------------ - ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin > sensitization - > ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity - ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation A - ISO 6872: 2015 Dentistry Ceramic materials > - 8. Clinical Test Conclusion No clinical study is included in this submission. #### Substantially Equivalent (SE) Comparison 9. | | Proposed Device (K223194) | Predicate Device (K141727) | | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | ITEM | | Dental Lithium Disilicate Glass Ceramic Block<br>(Up. CAD Series) | Remark | | Product Code | EIH | EIH | SAME | | Regulation No. | 21 CFR 872.6660 | 21 CFR 872.6660 | SAME | | Class | II | II | SAME | | Indication for<br>Use | Glass Ceramic is indicated for<br>fabricating all ceramic restorations<br>such as veneers, inlay/ onlay, partial<br>crowns, anterior crowns, posterior<br>crowns, using the CAD/CAM system. | Dental Lithium Disilicate Glass Ceramic Blocks<br>(Up. Press Series and Up. CAD Series) are<br>indicated for fabricating all ceramic restorations<br>such as veneers, inlay/ onlay, partial crowns,<br>anterior crowns, posterior crowns, using the hot<br>press technique or CAD/CAM system. | SIMILAR | | Materials | SiO2, Li2O, K2O, P2O5, Al2O3<br>and other oxides | SiO2, Li2O, K2O, P2O5, Al2O3, B2O3,<br>and other oxides | SIMILAR | | Summary of<br>sizes and shapes | Various | Various | SAME | | Shade | Various | Various | SAME | | Single Use | Yes | Yes | SAME | | Principle of<br>operation | CAD/CAM | CAD/CAM (Up. CAD Series) | SAME | | Sterile | Non-sterile | Non-sterile | SAME | #### Table 5-1 General Comparison {6}------------------------------------------------ | ITEM | Proposed<br>Device<br>K223194 | Predicate<br>Device<br>K141727 | Reference<br>Device<br>K051705 | Requirement of ISO 6872 | Remark | |-----------------------------------------|--------------------------------|--------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Uniformity | Conformance<br>to requirements | Conformance to<br>requirements | Conformance<br>to requirements | The inorganic pigment(s) used to<br>produce the colour of a fired dental<br>ceramic and any organic colorants (for<br>colour coding) shall be uniformly<br>dispersed throughout the dental ceramic<br>material and in powdered ceramic<br>products, no segregation of the<br>pigment(s) shall take place when the<br>powder is mixed as in ISO 6872:2015<br>7.1.3.Check by visual inspection. | SAME | | Freedom from<br>extraneous materials | Conformance<br>to requirements | Conformance to<br>requirements | Conformance<br>to requirements | Dental ceramic materials shall be free<br>from extraneous materials when<br>assessed by visual inspection. | SAME | | Radioactivity | < 1.0Bq·g⁻¹<br>of ²³⁸U | < 1.0Bq·g⁻¹ of<br>²³⁸U | < 1.0Bq·g⁻¹<br>of ²³⁸U | Dental ceramic materials shall not have<br>an activity concentration of more than<br>1.0Bq·g⁻¹ of ²³⁸U. Test in accordance<br>with ISO6872:2015 7.22. | SAME | | Biaxial flexure | 308.4MPa | / | 530MPa | Type II Class2 > 100MPa | Different 1 | | Linear thermal<br>expansion coefficient | 10.8×10⁻⁶K⁻¹ | (8.5-11)×10⁻⁶K⁻¹ | / | The coefficient of thermal expansion of<br>the ceramics shall not deviate by more<br>than 0,5×10⁻⁶K⁻¹ from the value stated<br>by the manufacturer. | SIMILAR | | Glass transition<br>temperature | 553.5°C | / | / | The glass transition temperature of the<br>ceramics shall not deviate by more than<br>20 °C from the value stated by the<br>manufacturer. | Different 2 | | Chemical solubility | 9.5µg·cm⁻² | <100µg·cm⁻² | / | Type II Class2 < 100µg·cm⁻² | SIMILAR | | Fracture toughness | 3.83MPa√m | / | 2.11MPa√m | Type II Class2 >1MPa√m | Different 3 | | | Table 5-2 Performance Comparison | | |--|----------------------------------|--| | | | | | | | | Note: " / " means that it cannot be got. Different 1: The proposed device is different from K051705 on biaxial flexure strength, the proposed device is Type 2 Class 2. According to ISO 6872, the biaxial flexure strength of Type 2 Class 2 should be greater than 100MPa. We have conducted performance tests, and the test results show that Glass Ceramic can meet the requirements of Type 2 Class 2, so this difference does not increase any risk of effectiveness. {7}------------------------------------------------ #### Different 2: We cannot get the glass transition temperature of predicate device, so the proposed device may be different from predicate device on glass transition temperature. According to ISO 6872, the glass transition temperature of the ceramics shall not deviate by more than 20°C from the value stated by the manufacturer. The glass transition temperature of ceramics specified by us is 555°C, and the test results of ISO 6872 show that the deviation does not exceed 20℃, so this difference does not increase any risk of effectiveness. #### Different 3: The proposed device is different from K051705 on fracture toughness. According to ISO 6872, the Fracture toughness of Type 2 Class 2 should be greater than 1MPaym. We have conducted performance tests, and the test results show that Glass Ceramic can meet the requirements of Type 2 Class 2 and the proposed device is better than K0511705 on fracture toughness, so this difference does not increase any risk of effectiveness. | ITEM | Proposed Device<br>(K223194) | Predicate Device<br>(K141727) | Standard | Remark | |-------------------------------------------|--------------------------------|--------------------------------|--------------------------------|--------| | Cytotoxicity<br>(Agar diffusion) | Conformance to<br>requirements | Conformance to<br>requirements | ISO 10993-5 | SAME | | Sensitization | Conformance to<br>requirements | Conformance to<br>requirements | ISO 10993-10 | SAME | | Acute systemic toxicity<br>(Oral) | Conformance to<br>requirements | Conformance to<br>requirements | ISO 10993-11 /<br>ISO 10993-23 | SAME | | Oral mucosa irritation | Conformance to<br>requirements | Conformance to<br>requirements | ISO 10993-10 | SAME | | Bacterial reverse mutation<br>(Ames test) | Conformance to<br>requirements | Conformance to<br>requirements | ISO 10993-3 | SAME | #### Table 5-3 Biocompatibility Comparison #### 10. Substantially Equivalent (SE) Conclusion The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K141727).