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Neodent Implant System CM Drive Implants

by Jjgc Industria E Comercio DE Materiais Dentarios S

510(k) K150182

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) K150182↗

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 · Special NumberK150182 Date23 Apr 2015ClearedStatusActive
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  • Withdrawn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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
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 Neodent Implant System CM Drive Implants are dental implants classified under the nomenclature category for endosseous dental implants. These devices are designed to replace missing teeth by integrating with the jawbone, providing a stable foundation for prosthetic teeth or restorations. The CM Drive series features a specific implant design optimized for primary stability during osseointegration.

These implants are supplied sterile and intended for single-use in oral and maxillofacial surgical procedures. They are regulated under FDA 510(k) clearance (K150182) and comply with EU MDR requirements. The system includes various sizes and configurations, as specified in the product documentation, and must be handled and stored according to manufacturer instructions to maintain sterility and integrity. No MRI safety information is provided in the available data.

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