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3I Osseotite Dental Implants

by Implant Innovations, Inc. 510(k)

Active United States

510(k) K051461

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051461 Date15 Sep 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 3i Osseotite Dental Implants are root-form endosseous dental implants designed for surgical placement in the upper or lower jaw. These devices feature an acid-etched surface, which may be treated with nano-crystals of calcium phosphate, to facilitate osseointegration and support prosthetic attachments such as single crowns.

The implants are available in tapered or parallel-walled designs with either external hex or internal connections. These devices have received FDA 510(k) clearance for use by dental professionals in oral reconstruction procedures.

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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 primary purpose of 3i Osseotite Dental Implants?

    These devices are root-form endosseous dental implants intended for surgical placement into the upper or lower jaw. They are designed to support prosthetic attachments, such as single crowns, during oral reconstruction procedures performed by dental professionals.

  • What design features assist with osseointegration?

    The implants feature an acid-etched surface to facilitate osseointegration. This surface may also be treated with nano-crystals of calcium phosphate to further support the integration process with the surrounding bone.

  • What configuration options are available for these implants?

    The implants are available in two primary geometric designs: tapered or parallel-walled. Additionally, they are manufactured with either external hex or internal connections to accommodate different surgical and prosthetic requirements.

  • What is the regulatory status of the 3i Osseotite Dental Implants?

    These devices have received FDA 510(k) clearance under the classification of substantially equivalent, allowing them to be used by dental professionals for oral reconstruction.