CZR Press LF Stains
510(k) K050920
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050920 | Date11 May 2005 | 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- Withdrawn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
- 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, 19 Sep 2026
The CZR Press LF Stains is a low-fusing porcelain designed for dental restorations, specifically as an enamel layer material for pressed ceramic ingots. It is classified as a dental porcelain for veneering and is used in conjunction with zirconia-free pressed ceramic frameworks to create anterior single crowns, porcelain laminate veneers, inlays, and onlays. This material leverages the aesthetic versatility and marginal integrity of pressable ceramics while maintaining the strength and durability required for dental applications.
This porcelain is supplied as a dental material for use in laboratory settings by dental technicians. It is intended for single-use applications and requires proper handling and storage as per manufacturer guidelines. The product is regulated under FDA 510K clearance (K050920) and is categorized under the Dental (EIH) product code, ensuring compliance with dental device standards. No specific sterility or MRI safety information is provided in the available data.