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Neodent Implant System, Titamax Ti Ex Acqua and Ti Drive Acqua, Titamax Smart Ex Acqua and Drive Smart Acqua, Titamax Cm

by Neodent USA, Inc.

510(k) K133592

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK133592 Date22 Aug 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 21 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 consists of endosseous dental implants designed for surgical placement in jawbone to provide structural support for prosthetic artificial teeth. The system includes various implant designs such as Titamax, Ti Drive, CM Drive, and Smart series.

The CM Drive Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants, with the only difference being the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The device is authorized under FDA 510K clearance with product code DZE.

Questions

AI-generated answers, 21 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 Neodent Implant System used for?

    The Neodent Implant System consists of endosseous dental implants designed for surgical placement in jawbone to provide structural support for prosthetic artificial teeth. The system includes various implant designs such as Titamax, Ti Drive, CM Drive, and Smart series.

  • What is the difference between CM Drive Acqua and Titamax CM EX implants?

    The CM Drive Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants, with the only difference being the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish.

  • What is the regulatory status of the Neodent Implant System?

    The device is authorized under FDA 510K clearance with product code DZE. It received FDA clearance on August 22, 2014, with decision code SESE indicating substantial equivalence.

  • What models are included in the Neodent Implant System?

    The system includes various implant designs including Titamax Ti Ex Acqua, Ti Drive Acqua, Titamax Smart Ex Acqua, Drive Smart Acqua, and Titamax CM models, each designed for specific clinical applications.