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Osteo Titanium Dental Implant

by Osteo Implant Corp.

510(k) K862854

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 NumberK862854 Date10 Feb 1987ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Osteo Titanium Dental Implant is an endosseous dental implant classified as a dental device. It is designed to be surgically inserted into the bone of the upper or lower jaw to provide stable support for prosthetic dental restorations, such as artificial teeth, thereby restoring chewing function and oral function.

This implant is supplied as a single-use, sterile device intended for surgical placement by dental professionals. It is manufactured from titanium and is regulated under FDA 510(k) clearance (K862854) as substantially equivalent to a predicate device. The device is intended for use in oral and maxillofacial surgical settings and adheres to dental implant standards for biocompatibility and osseointegration.

Other devices from Osteo Implant Corp.

  • Bone Drill

    Class II

Questions

AI-generated answers, 1 Oct 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 Osteo Titanium Dental Implant used for?

    The Osteo Titanium Dental Implant is designed to replace missing teeth by being surgically inserted into the jawbone. It provides a stable foundation for prosthetic restorations, such as crowns or bridges, to restore chewing and oral function. The implant integrates with the bone (osseointegration) to mimic natural tooth roots, ensuring long-term stability.

  • Is the Osteo Titanium Dental Implant single-use or reusable?

    The Osteo Titanium Dental Implant is supplied as a single-use device. This ensures sterility and safety for each patient, as reusing implants could compromise integrity and introduce infection risks. Each implant is sterile upon packaging and intended for one-time surgical placement by dental professionals.

  • What material is the implant made from, and why?

    The implant is manufactured from titanium, a biocompatible material known for its strength and resistance to corrosion. Titanium’s ability to bond with bone (osseointegration) makes it ideal for dental implants, ensuring stability and reducing the risk of rejection or failure over time.

  • How is the Osteo Titanium Dental Implant sterilized and packaged?

    The implant is supplied sterile, ready for immediate surgical use. Sterilization methods are not specified in the provided data, but the single-use packaging ensures no cross-contamination. Dental professionals should follow manufacturer guidelines for opening and handling to maintain sterility until implantation.

  • What regulatory approval does the Osteo Titanium Dental Implant hold?

    The implant holds FDA 510(k) clearance (K862854), classified as substantially equivalent to a predicate device. This approval confirms it meets U.S. regulatory standards for safety and effectiveness as an endosseous dental implant. The clearance was granted under the Dental (DE) advisory committee in 1987.