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Integral Omniloc Dental Implant With Interface Ring

by Calcitek, Inc.

510(k) K941608

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 NumberK941608 Date5 May 1995ClearedStatusActive

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  • Withdrawn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, 25 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 Integral Omniloc Dental Implant With Interface Ring is a hydroxyapatite-coated endosseous implant used for single-tooth replacement. It is designed to be placed in the jawbone to support a dental prosthesis. The implant is intended to provide a stable and durable foundation for tooth replacement. The device is a type of dental implant, classified under the product code DZE.

The Integral Omniloc Dental Implant With Interface Ring is supplied with FDA 510K clearance, indicated by the clearance number K941608. It is manufactured by Calcitek, Inc. and has been cleared for use since May 5, 1995. The device is available for use in dental procedures, and its success and maintenance requirements have been evaluated over a 5-year period.

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Questions

AI-generated answers, 25 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 Integral Omniloc Dental Implant With Interface Ring used for?

    This device is a hydroxyapatite-coated endosseous implant designed for single-tooth replacement. It is placed in the jawbone to provide a stable and durable foundation for supporting a dental prosthesis.

  • How is the device supplied and what is its regulatory status?

    The Integral Omniloc Dental Implant With Interface Ring is supplied with FDA 510K clearance, specifically under clearance number K941608. It has been cleared for use since May 5, 1995.

  • What is the intended use period for this dental implant?

    The device's success and maintenance requirements have been evaluated over a 5-year period, indicating it is intended for long-term use in dental procedures.