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Odontit Osseointegrated Implants System

by Odontit Systeme

510(k) K915375

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 NumberK915375 Date3 Jun 1992ClearedStatusActive

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  • Withdrawn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 Odontit Osseointegrated Implants System is a dental implant system designed for osseointegration in dental applications. It is a substantially equivalent device cleared through the FDA 510(k) process under product code DZE.

The system is supplied as a reusable or single-use implant system (as per specifications) and is intended for use in dental surgical settings. It includes implants available in various sizes and is authorized for marketing in the United States under FDA 510(k) clearance K915375, with no claims made regarding MRI safety, sterility, or storage conditions beyond what is explicitly stated in the data.

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 Odontit Osseointegrated Implants System used for?

    The Odontit Osseointegrated Implants System is designed for osseointegration in dental applications, meaning it is intended to integrate with bone to support dental prosthetics in surgical dental settings.

  • How is the Odontit Osseointegrated Implants System supplied?

    The system is supplied as either reusable or single-use, depending on the specific implant specifications, allowing flexibility based on clinical needs and manufacturer guidelines for each component.

  • What regulatory pathway was used for the Odontit Osseointegrated Implants System?

    The device received FDA 510(k) clearance under K915375 as a substantially equivalent device, meaning it was determined to be as safe and effective as a legally marketed predicate product under product code DZE for dental implants.