Luxor Porcelain
by Jeneric Ind.
510(k) K820057
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820057 | Date2 Mar 1982 | 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- Withdrawn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, 21 Sep 2026
Luxor Porcelain is a dental porcelain device used for dental restorations and prosthetics. It is designed to provide aesthetic and functional solutions for dental applications.
The device is supplied as a dental material and is intended for use in dental procedures. It is regulated under FDA 510K clearance with product code EIH and is manufactured by Jeneric Ind.
Other devices from Jeneric Ind.
Questions
AI-generated answers, 21 Sep 2026
What is Luxor Porcelain used for in dental applications?
Luxor Porcelain is a dental porcelain device designed to provide aesthetic and functional solutions for dental restorations and prosthetics. It is supplied as a dental material for use in various dental procedures.
How is Luxor Porcelain supplied and what are its regulatory specifications?
Luxor Porcelain is supplied as a dental material. It is regulated under FDA 510K clearance with product code EIH, manufactured by Jeneric Ind., and received traditional clearance in 1982.
Is Luxor Porcelain single-use or reusable?
The device data does not specify whether Luxor Porcelain is single-use or reusable. As a dental porcelain material used for restorations and prosthetics, its usage would depend on the specific dental procedure and clinical judgment.
What sizes and models of Luxor Porcelain are available?
The device data does not provide information about specific sizes or models of Luxor Porcelain. As a dental porcelain material, it may be available in various forms suitable for different dental restoration needs.