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Ultracrown 75 Alloy

by Dentsply International

510(k) K032851

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 · Special NumberK032851 Date26 Sep 2003ClearedStatusActive

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  • Withdrawn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
EJT
Device class
Class II
Regulation
21 CFR Part 872.3060
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Ultracrown 75 Alloy is a gold-based noble metal alloy used in dental applications. It is classified as Alloy, Gold-Based Noble Metal under product code EJT and device class II with special controls.

The device is supplied by Dentsply International and received FDA 510(k) clearance (K032851) on September 26, 2003, following submission on September 12, 2003. It is regulated under regulation number 872.3060 and is substantially equivalent to a legally marketed device.

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Questions

AI-generated answers, 26 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 Ultracrown 75 Alloy used for?

    Ultracrown 75 Alloy is a gold-based noble metal alloy used in dental applications, specifically for fabricating dental restorations such as crowns and bridges where biocompatibility, corrosion resistance, and mechanical properties of gold alloys are required.

  • How is Ultracrown 75 Alloy supplied and is it sterile or single-use?

    Ultracrown 75 Alloy is supplied as a raw alloy material by Dentsply International for use in dental laboratory processes; it is not provided sterile nor as a single-use device, as it is intended to be melted, cast, and processed by dental technicians into final restorations.

  • What regulatory pathway was used for Ultracrown 75 Alloy and what is its classification?

    Ultracrown 75 Alloy received FDA 510(k) clearance (K032851) on September 26, 2003, and is classified as a Class II medical device under product code EJT, with regulation number 872.3060, based on substantial equivalence to a legally marketed predicate device.