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Alexander

by Ivoclar Vivadent, Inc.

510(k) K032493

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032493 Date4 Sep 2003ClearedStatusActive

Official records

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  • Withdrawn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
EJT
Device class
Class II
Regulation
21 CFR Part 872.3060
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.

Alexander is a gold-based noble metal alloy used in dental applications. It is classified as a dental device intended for use in restorative procedures.

This device is regulated under FDA 510(k) clearance. It is manufactured by Ivoclar Vivadent, Inc. and is categorized under dental regulation number 872.3060.

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