Yttria-Stabilized Zirconia Ceramic Products
510(k) K113431
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113431 | Date30 Mar 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Ceramic Products Made in Yttria-Stabilized Zirconia
- 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, 1 Oct 2026
The device is a ceramic product manufactured from yttria-stabilized zirconia, classified under product code EIH as a dental powder or porcelain material. Yttria-stabilized zirconia is a high-strength, biocompatible ceramic used primarily in dental restorations, including crowns, bridges, and inlays, due to its durability and aesthetic properties. This material is designed to withstand mechanical stresses in oral environments while maintaining long-term stability and biocompatibility with surrounding tissues. Its composition ensures resistance to wear and fracture, making it suitable for load-bearing dental applications.
These ceramic products are supplied as dental-grade materials intended for use in clinical settings by dental professionals. The device is sterile and intended for single-use in dental procedures, though specific sterilization instructions must be followed as per manufacturer guidelines. The product adheres to FDA 510(k) clearance (K113431) under the Dental (DE) Advisory Committee, with a Traditional Review classification. Storage conditions and handling should comply with dental material protocols to preserve integrity and sterility prior to use.
Questions
AI-generated answers, 1 Oct 2026
What is yttria-stabilized zirconia dental powder used for?
Yttria-stabilized zirconia dental powder is primarily used in dental restorations, such as crowns, bridges, and inlays. Its high strength and biocompatibility make it ideal for load-bearing applications where durability and aesthetic properties are critical. The material resists wear and fracture, ensuring long-term stability in oral environments while maintaining compatibility with surrounding tissues.
How is this ceramic product supplied and intended for use?
This ceramic product is supplied as a sterile, dental-grade material designed exclusively for clinical use by dental professionals. It is intended for single-use in dental procedures, though specific sterilization protocols must be followed if reprocessing is required. The material adheres to FDA 510(k) clearance (K113431) and is classified under product code EIH for dental powders or porcelain materials.
Is the yttria-stabilized zirconia material reusable or single-use?
The product is intended for single-use in dental procedures, though the manufacturer’s guidelines should be consulted for any specific sterilization or reprocessing instructions. Its sterile packaging ensures safety for clinical applications, and adherence to dental material protocols is recommended to maintain integrity and sterility prior to use.
What storage conditions should be followed for this dental material?
To preserve the integrity and sterility of the yttria-stabilized zirconia dental powder, storage should comply with standard dental material protocols. This includes protecting the product from moisture, contamination, and extreme temperatures. Always follow the manufacturer’s instructions for optimal handling and storage to ensure the material remains suitable for clinical use.
What regulatory clearance does this product hold?
This product holds FDA 510(k) clearance under the Dental (DE) Advisory Committee, with a Traditional Review classification. The clearance number is K113431, and the device is classified under product code EIH as a dental powder or porcelain material. The clearance confirms its substantial equivalence to a predicate device and compliance with applicable regulations.