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Ultra-Etch Enamel Preparation Product Line

by Ultradent Products, Inc.

510(k) K931867Ref 383, 1407, 685-CE

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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) K931867↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF016AS Basic UDI-DI Date29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205103109 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK931867 Date9 Sep 1993ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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) · GUDID

Trade Name
Ultra-Etch
Generic Name
Dental tooth-etching solution
Device Name
UltraEtch
Model / Ref / Catalog
1407, 383, 685-CE
Primary DI / UDI-DI
00883205103109, 00883205105608, 00883205107541
Basic UDI-DI
0883205-TF016AS
510(k) Number
FDA Product Code
EBF
EMDN Code
Q01010402 Enamel-dentinal etching materials
GMDN Term
Dental tooth-etching solution
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 872.3690
EU market of registration
Germany
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

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 Ultra-Etch Enamel Preparation Product Line is a dental device classified under the product code EBF for enamel preparation. It is designed to condition and prepare tooth enamel prior to bonding procedures, enhancing adhesion for restorative materials through controlled acid etching.

This product line is supplied as a single-use dental preparation system and is intended for use in clinical dental settings. It is not sterile at the time of shipment but is intended to be used in a manner that maintains sterility during application. The device holds FDA 510(k) clearance under the Traditional pathway and is also compliant with MDR requirements. No MRI safety information is specified.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

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 Ultra-Etch Enamel Preparation Product Line used for in a clinical setting?

    The Ultra-Etch Enamel Preparation Product Line is specifically designed to condition and prepare tooth enamel before bonding procedures. It works by creating micro-retentions in the enamel through controlled acid etching, which improves adhesion for restorative materials like composites or other dental fillings.

  • Is the Ultra-Etch Enamel Preparation Product Line intended for single-use or can it be reused?

    The Ultra-Etch Enamel Preparation Product Line is supplied as a single-use dental preparation system. While it is not sterile at the time of shipment, it is intended to be used in a way that maintains sterility during application, meaning it should not be reused after a single clinical application.

  • How is the Ultra-Etch Enamel Preparation Product Line regulated, and what pathway was used for FDA clearance?

    The Ultra-Etch Enamel Preparation Product Line holds FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Regulation (MDR) requirements, ensuring it meets both U.S. and EU regulatory standards.

  • What type of dental procedures is this product line intended for, and how does it enhance the bonding process?

    This product line is intended for enamel preparation in clinical dental settings, specifically to enhance adhesion during restorative procedures. By etching the enamel, it creates microscopic irregularities that improve the mechanical bond between the tooth surface and restorative materials, ensuring better durability and longevity of the restoration.

Properties

  • Prescription Use
  • Convenience Kit NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No