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Amaris Gingiva Opaquer

by VOCO GmbH

510(k) K090843

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) K090843↗

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 NumberK090843 Date17 Jun 2009ClearedStatusActive
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  • Withdrawn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
EBF
Device class
Class II
Regulation
21 CFR Part 872.3690
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 Amaris Gingiva Opaquer is a dental material classified as a gingival opacifier (Product Code: EBF), designed to mask discoloration in gingival tissues during restorative procedures. It provides visual contrast between the gingiva and dental restorations, improving the accuracy of margin placement and aesthetic outcomes in dental work.

Supplied as a single-use, non-sterile powder-liquid system, this device is intended for use in dental offices and clinics. The kit includes a mixing pad, spatula, and application tools, with no specific MRI safety considerations noted. Storage requires protection from moisture and extreme temperatures, and it is regulated under FDA 510(k) clearance and MDR compliance as a Class II medical device.

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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 Amaris Gingiva Opaquer used for in dental procedures?

    The Amaris Gingiva Opaquer is specifically designed to mask discoloration in gingival tissues during restorative dental work. By providing visual contrast between the gum and dental restorations, it helps clinicians achieve more precise margin placement and enhances the aesthetic outcome of treatments like crowns, bridges, or fillings.

  • Is the Amaris Gingiva Opaquer sterile, and how is it supplied?

    The Amaris Gingiva Opaquer is supplied as a non-sterile powder-liquid system intended for single-use only. Each kit includes a mixing pad, spatula, and application tools, ensuring convenience for dental offices and clinics without requiring additional sterilization steps.

  • What storage conditions are required for the Amaris Gingiva Opaquer?

    To maintain its integrity, the Amaris Gingiva Opaquer must be stored in a dry environment, protected from moisture and extreme temperatures. Proper storage ensures the material remains effective for its intended use in dental procedures.

  • How is the regulatory status of the Amaris Gingiva Opaquer determined?

    The Amaris Gingiva Opaquer is classified as a Class II medical device under both FDA 510(k) clearance (with a decision dated June 17, 2009) and MDR compliance. Its regulatory route was determined through a Traditional 510(k) review by the FDA’s Dental Advisory Committee, confirming it is substantially equivalent to existing devices in its category (Product Code: EBF).