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VITA VMLC Primer

by VITA Zahnfabrik H. Rauter GmbH & Co. KG

510(k) K251587

Active European Union and United States

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) K251587↗

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 NumberK251587 Date23 Feb 2026ClearedStatusActive
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  • Withdrawn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
KLE
FDA applicant
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Device Class
Class II
Regulation
21 CFR Part 872.3200
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 VITA VMLC Primer is a resin-based agent for tooth bonding, classified as a dental adhesive primer. It is designed to prepare the tooth surface for improved bonding with composite resins, enhancing the durability and strength of restorative procedures in dental prosthetics.

This single-use, sterile primer is supplied in a dental setting for use with resin-based restorative materials. It is regulated under the MDR and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The product is intended for dental professionals and must be stored according to manufacturer instructions to maintain sterility and efficacy.

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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 VITA VMLC Primer used for in dental procedures?

    The VITA VMLC Primer is a resin-based dental adhesive primer designed to prepare tooth surfaces for bonding with composite resins. Its purpose is to enhance the durability and strength of restorative dental procedures, ensuring a more secure and long-lasting bond between the tooth and restorative materials.

  • Is the VITA VMLC Primer single-use or reusable, and how should it be stored?

    The VITA VMLC Primer is a single-use product and is supplied sterile for dental settings. To maintain its sterility and efficacy, it must be stored according to the manufacturer’s instructions, which likely include keeping it in a clean, dry environment away from direct sunlight or extreme temperatures.

  • What regulatory pathways has the VITA VMLC Primer followed, and where is it manufactured?

    The VITA VMLC Primer has received FDA 510(k) clearance, demonstrating it is substantially equivalent to a predicate device, and it is also authorized under the Medical Device Regulation (MDR). It is manufactured by VITA Zahnfabrik H. Rauter GmbH & Co. KG, located at Spitalgasse 3, Bad Sackingen, Baden-Württemberg, Germany.

  • How is the VITA VMLC Primer classified, and what type of dental procedures is it intended for?

    The VITA VMLC Primer is classified as a Class II dental device under the FDA’s regulatory framework (device class: 2, regulation number: 872.3200). While it is intended for dental professionals, its specific indication is to prepare tooth surfaces for bonding with resin-based restorative materials, improving the longevity of dental restorations rather than being tied to a particular procedure type.