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Vitadur Alpha Porcelain

by Vident

510(k) K921623

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 NumberK921623 Date2 Jul 1992ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The device is a powder porcelain material used in dental applications. It is classified under product code EIH as a Class II medical device with special controls.

It was cleared by the FDA through the 510(k) process under K921623 on July 2, 1992, following a traditional review. The device is manufactured by Vident in Baldwin Park, California, and is intended for dental use as indicated by its classification and review panel.

Other devices from Vident

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Questions

AI-generated answers, 6 Oct 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 VITADUR ALPHA PORCELAIN used for?

    VITADUR ALPHA PORCELAIN is a powder porcelain material intended for dental applications, as indicated by its classification under product code EIH and its review by the Dental advisory committee.

  • How is VITADUR ALPHA PORCELAIN supplied and is it sterile or single-use?

    The device data does not specify the supply format, sterility, or single-use/reuse status of VITADUR ALPHA PORCELAIN; only its classification as a powder porcelain material for dental use and its FDA 510(k) clearance are provided.

  • What regulatory pathway was used for VITADUR ALPHA PORCELAIN?

    VITADUR ALPHA PORCELAIN was cleared by the FDA through the 510(k) process under K921623 on July 2, 1992, following a traditional review, as stated in the device data.