Glass Ceramic

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION December 8, 2025 Shenzhen Xiangtong Co., Ltd. Xue Gong RA Manager Rm. 101,301,701,801, Bldg. 1, #110, Guanchang Rd. Dalingshan Town Dongguan, Guangdong 523800 China Re: K252789 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: September 2, 2025 Received: September 2, 2025 Dear Xue Gong: 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 &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K252789 - Xue Gong 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} K252789 - Xue Gong 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} 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) K252789 | | | Device Name Glass Ceramic | | | Indications for Use (Describe) Glass Ceramic is used for the preparation of veneers, inlays, onlays, crowns, and three-unit bridges not involving molar restoration using hot press or CAD/CAM techniques. | | | 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} Glass Ceramic SHENZHEN XIANGTONG CO.,LTD. # 510(k) Summary Date of Summary Preparation: August 29, 2025 This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR Part 807.92. The assigned 510(K) number is: K252789 ## 1. Submitter's Identification Submitter's name: SHENZHEN XIANGTONG CO.,LTD. Address: Room 101,301,701,801, Building 1, No.110, Guanchang Road, Dalingshan Town, Dongguan, 523800 Guangdong, P.R.China. Tel: +86-0755-86001801 Email: xtcera@xianton.com Website: en.xtcera.com Contact person: Xue Gong Title: RA Manager Tel: +86-13760477635 Email: gongx@xianton.com ## 2. Device Identification Type of 510(k) submission: Abbreviated Device common name: Dental porcelain/ceramic Device Name/Proprietary Name/Trade Name: Glass Ceramic Classification Name: Porcelain powder for clinical use Classification Regulation: 21 CFR 872.6660 Class: Class 2 Panel: Dental Product code: EIH ## 3. Legally marketed predicate device K230487, “Dental Lithium Disilicate Glass-Ceramic”, manufactured by “Fuzhou Rick Brown Biomaterials CO.,LTD.” (Primary predicate) ## 4. Indications for use Glass Ceramic is used for the preparation of veneers, inlays, onlays, crowns, and three-unit bridges not involving molar restoration using hot press or CAD/CAM techniques. ## 5. Device Description Glass Ceramic products are grouped into two main categories: CAD/CAM Glass Ceramic and Hot Press Glass Ceramic. CAD/CAM Glass Ceramic shapes include rectangular and customized shapes, 510(K) Summary {5} Glass Ceramic SHENZHEN XIANGTONG CO.,LTD. and Hot Press Glass Ceramic shapes include rectangular, cylinder, and customized shapes. Glass Ceramic is available in 33 colors, and its performance conforms to ISO 6872 Dentistry: Ceramic Materials. Glass Ceramic is composed of silicon dioxide, lithium oxide, potassium oxide, phosphorus pentoxide, aluminum oxide and other oxides. This product is for prescription use only. 510(K) Summary 2 / 6 {6} Glass Ceramic SHENZHEN XIANGTONG CO.,LTD. 6. Substantially Equivalent Comparison | Description | Subject device | Predicate device | Comment | | --- | --- | --- | --- | | 510(k) Owner | SHENZHEN XIANGTONG CO.,LTD. | Fuzhou Rick Brown Biomaterials CO.,LTD | --- | | Device Name | Glass Ceramic | Dental Lithium Disilicate Glass-Ceramic | --- | | Product code | EIH | EIH | Same | | Regulation number | 21 CFR 872.6660 | 21 CFR 872.6660 | Same | | Classification | Class 2 | Class 2 | Same | | Indications for use | Glass Ceramic is used for the preparation of veneers, inlays, onlays, crowns, and three-unit bridges not involving molar restoration using hot press or CAD/CAM techniques. | Dental Lithium Disilicate Glass-Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges. | Same Differences in textual descriptions | | Material | SiO2, Li2O, K2O, P2O5, Al2O3and other oxides | SiO2, Li2O, K2O, Al2O3,P2O5, ZrO2and other oxides | Similar | | Use | Prescription | Prescription | Same | | Shape and Crystallization State as Supplied | Rectangular:Partially crystallized, final crystallization done by dental laboratory Cylinder:Fully crystallized | Cuboid:Partially crystallized, final crystallization done by dental laboratory Cylinder:Fully crystallized | Same Differences in textual descriptions | | Shade | Various | Translucency: | Similar | 510(k) Summary {7} Glass Ceramic SHENZHEN XIANGTONG CO.,LTD. | | | High Translucency (HT) Medium translucency(MT) Low Translucency (LT) Medium Opacity (MO) High Opacity (HO) Shades: HT/MT/LT: 16 A-D and 4 Bleach MO: 5 MO 0 – MO 4 HO: 3 HO 0 – HO 2 | | | --- | --- | --- | --- | | Sterile | Non-sterile | Non-sterile | same | | Single Use | Yes | Yes | same | | Type, class of dental ceramic | Type II, Class 3 | Type II, Class 3 | same | | Uniformity | Meet the requirements of ISO 6872 | Not Reported | The subject device meets ISO 6872 requirements | | Freedom from | Freedom from extraneous materials | Freedom from extraneous materials | same | 510(k) Summary 4 / 6 {8} Glass Ceramic SHENZHEN XIANGTONG CO.,LTD. | extraneous materials | | | | | --- | --- | --- | --- | | Radioactivity | Dental ceramic materials shall not have an activity concentration of more than 1.0 Bq·g^{-1} of 238 U | Meets ISO 6872 requirements ≤ 1.0 Bq/g of ^{238}U | same | | Biaxial flexural strength | ≥300Mpa | ≥300Mpa | same | | Chemical solubility | <100μg/cm^{2} | <100μg/cm^{2} | same | | Fracture toughness | ≥2.0MPa·m^{1/2} | Not Reported | The subject device meets ISO 6872 requirements | | Linear thermal expansion coefficient | (10.5±0.5)×10^{-6}K^{-1} | (9.8±0.5) x 10^{-6}/K | Similar | | Glass transition temperature | 555±20℃ | 495±20℃ | Different | | Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 7405: 2018 | Similar | Different: According to the standard ISO 6872:2024 “Dentistry - Ceramic Materials”, the glass transition temperature of the ceramics shall not deviate by more than 20℃ from the value stated by the manufacturer. The acceptance criteria for the subject device's glass transition temperature are 555±20℃. The test results indicate that the glass transition temperature of the subject device meets the requirements of the FDA consensus standard. Therefore, this difference does not raise a risk to safety and effectiveness. 510(k) Summary {9} Glass Ceramic SHENZHEN XIANGTONG CO.,LTD. 6 / 6 # 7. Non-Clinical performance data Test data to support the evaluation of the subject device Glass Ceramic have been submitted and included by reference as follows: - Product performance testing per ISO 6872, Dentistry - Ceramic materials. - Biocompatibility assessment as follows: - Evaluation per ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. - Genotoxicity assessment per ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. - Cytotoxicity assessment per ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. - Sensitization assessment per ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for skin sensitization. - Toxicity assessment per ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. - Irritation assessment per ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation. # 8. Substantial equivalence conclusion The subject device, "Glass Ceramic," and the predicate device, "Dental Lithium Disilicate Glass-Ceramic," have the same indications for use and similar technological characteristics. Both the subject and predicate devices have been tested according to the same ISO 6872 (Dentistry-Ceramic materials) standard and met the same specification requirements of Type II, Class 3 materials. The difference between the subject device and its predicate device does not raise any question regarding its equivalence. The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. This shows that the subject device and the predicate device are substantially equivalent. 510(k) Summary