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Ultradent Porcelain Etch

by Ultradent Products, Inc.

510(k) K951582

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K951582↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK951582 Date10 May 1995ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

The Ultradent Porcelain Etch is a dental etching agent designed for the preparation of porcelain surfaces prior to bonding procedures. It falls under the category of dental adhesives and bonding agents, specifically formulated to create a micro-retentive surface on porcelain restorations, enhancing adhesion with composite resins or other bonding materials.

This product is supplied as a single-use solution and is intended for use in dental offices. It is regulated under FDA 510K clearance and MDR compliance, with a product code of EIH. The device is non-sterile and must be stored in a cool, dry place, protected from direct sunlight. No specific MRI safety information is provided, and the device is reusable in terms of its packaging but the solution itself is single-use per application.

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Questions

AI-generated answers, 18 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 the Ultradent Porcelain Etch used for in dental procedures?

    The Ultradent Porcelain Etch is specifically designed to prepare porcelain surfaces before bonding. It creates a micro-retentive texture on porcelain restorations, which improves adhesion when bonding composite resins or other bonding materials. This helps ensure a stronger, more durable bond during dental restorative procedures.

  • Is the Ultradent Porcelain Etch single-use or reusable?

    The solution itself is intended for single-use per application, meaning each bottle is meant to be used once for etching porcelain surfaces. However, the packaging is reusable, as it can be used again for a new bottle of the product.

  • How should I store the Ultradent Porcelain Etch to maintain its effectiveness?

    The product must be stored in a cool, dry place, away from direct sunlight. Proper storage conditions help preserve its integrity and ensure it remains effective for use in dental procedures.

  • What regulatory pathways does the Ultradent Porcelain Etch follow?

    The device is regulated under both FDA 510K clearance and MDR compliance. It was originally cleared through a traditional 510(k) process in 1995, with a product code of EIH, and is classified under the dental category for adhesives and bonding agents.