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.

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, 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.

AI/ML Overview

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Summary

FDA 510(k) Clearance Letter - Glass Ceramic

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

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.

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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-

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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

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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"

FORM FDA 3881 (8/23) Page 1 of 1

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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,

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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.

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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, Al2O3 and other oxides	SiO2, Li2O, K2O, Al2O3,P2O5, ZrO2 and 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

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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

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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 ²³⁸U	Meets ISO 6872 requirements ≤ 1.0 Bq/g of ²³⁸U	same
Biaxial flexural strength	≥300Mpa	≥300Mpa	same
Chemical solubility	＜100μg/cm²	＜100μg/cm²	same
Fracture toughness	≥2.0MPa·m¹/²	Not Reported	The subject device meets ISO 6872 requirements
Linear thermal expansion coefficient	(10.5±0.5)×10⁻⁶K⁻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.

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Glass Ceramic

SHENZHEN XIANGTONG CO.,LTD.

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.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.