Skip to content

VITA ENAMIC Implant Solutions (IS)

by Vita Zahnfabrik H.Rauter GmbH & Co.

510(k) K153645

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) K153645↗

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 · Abbreviated NumberK153645 Date30 Jun 2016ClearedStatusActive
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  • Withdrawn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
NHA
FDA applicant
Vita Zahnfabrik H.Rauter GmbH Co.
Device Class
Class II
Regulation
21 CFR Part 872.3630
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 ENAMIC Implant Solutions (IS) is a dental implant system designed for use in oral and maxillofacial reconstruction. This device is categorized under dental implants and is formulated to provide a biocompatible foundation for restoring missing teeth, offering enhanced stability and integration with natural bone tissue.

The VITA ENAMIC Implant Solutions (IS) is supplied as a sterile, single-use implant system intended for surgical placement by dental professionals. It is regulated under the FDA’s 510(k) pathway with a Substantially Equivalent determination (K153645) and complies with the Medical Device Regulation (MDR). The system is available in various sizes and configurations tailored for specific clinical applications, with sterility maintained through manufacturer-controlled packaging.

Other devices from Vita Zahnfabrik H.Rauter GmbH & Co.