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Luxor Porcelain

by Jeneric Ind.

510(k) K820057

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820057 Date2 Mar 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

See all devices from Jeneric Ind. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.