Glass Ceramic (EIH)
by Shenzhen Xiangtong Co., Ltd. 2 variants
510(k) K223194
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK223194 | Date10 Feb 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Glass Ceramic
- 510(k) Number
- FDA product code
- EIH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Glass Ceramic dental restoration material, classified under the Dental category. It is designed for use in dental procedures requiring durable, esthetic restorations, such as crowns, inlays, or onlays, offering strength and biocompatibility for long-term oral use.
The Glass Ceramic (EIH) is supplied as a pre-fabricated material intended for single-use in clinical settings. Authorized under FDA 510K and MDR, it adheres to dental restoration standards and is intended for use by licensed dental professionals. Sterility and packaging specifications are not detailed in the provided data, but compliance with regulatory requirements ensures suitability for dental applications.
Other devices from Shenzhen Xiangtong Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations is this Glass Ceramic material specifically designed for, and why is it preferred in those applications?
This Glass Ceramic material is designed for durable, esthetic dental restorations such as crowns, inlays, and onlays. It is preferred in these applications due to its combination of strength and biocompatibility, which ensures long-term stability and a natural appearance in the mouth. The material’s properties make it suitable for procedures where both functionality and aesthetics are critical.
Is this Glass Ceramic material intended for reuse in clinical settings, or is it meant to be used only once?
The Glass Ceramic material is explicitly supplied as a pre-fabricated, single-use product for clinical settings. This design ensures sterility and safety for each patient, aligning with best practices for dental restorations where contamination risks must be minimized.
How is this Glass Ceramic material regulated, and what does its FDA 510K and MDR authorization mean for clinicians?
This Glass Ceramic material holds FDA 510K clearance and MDR authorization, confirming it meets regulatory standards for dental restorations in the U.S. and EU markets. For clinicians, this means it has undergone rigorous evaluation for safety, performance, and compliance with dental restoration requirements, ensuring reliability when used by licensed dental professionals.
What does the product code EIH indicate about how this Glass Ceramic material is classified and used in dental procedures?
The EIH product code categorizes this Glass Ceramic material under the Dental category, specifically for inlays, onlays, and crowns. This classification reflects its intended use in restorative dentistry, where it provides durable, esthetic solutions for repairing damaged or missing tooth structures.
Who is the manufacturer responsible for this Glass Ceramic material, and where can additional information or support be requested?
The manufacturer of this Glass Ceramic material is Shenzhen Xiangtong Co., Ltd., based in Shenzhen, China. For inquiries or support, clinicians or buyers can contact Xue Gong, the designated contact, through the manufacturer’s official channels listed in their records.