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Replace HA Coated Implants

by Steri-Oss, Inc.

510(k) K962845

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 NumberK962845 Date18 Oct 1996ClearedStatusActive

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  • Withdrawn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, 19 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 Replace HA Coated Implants are dental implants classified under product code DZE, designed for osseointegration in the jawbone to support dental prostheses. These implants feature a hydroxyapatite (HA) coating to enhance bone integration and stability, aiding in the restoration of missing teeth.

Intended for single-use in surgical settings, these implants are supplied sterile and require professional placement by dental practitioners. The device was cleared under the FDA’s Traditional 510(k) pathway as substantially equivalent to a predicate, with no indication of MRI safety or reusable applications. Storage and handling must comply with sterile instrument protocols as per regulatory guidelines.

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Questions

AI-generated answers, 19 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 the hydroxyapatite (HA) coating on these dental implants, and how does it benefit the patient during recovery?

    The hydroxyapatite (HA) coating on the Replace HA Coated Implants is designed to enhance osseointegration, which is the process where bone grows directly onto the implant surface. This promotes faster and stronger bone integration in the jawbone, improving stability and aiding in the successful restoration of missing teeth by supporting dental prostheses.

  • Are these implants intended for reuse in multiple patients, or are they meant for single-use only?

    These implants are explicitly intended for single-use only in surgical settings. The FDA clearance under the Traditional 510(k) pathway does not include any indication for reuse, and the device is supplied sterile for professional placement by dental practitioners.

  • How should these implants be stored and handled to maintain sterility before use?

    Since these implants are supplied sterile, they must be stored and handled according to sterile instrument protocols as required by regulatory guidelines. This ensures their integrity and safety for single-use in surgical environments.

  • What types of dental prostheses can these implants support, and are they suitable for all jawbone conditions?

    These implants are designed to support dental prostheses in the jawbone through osseointegration, but their suitability depends on individual patient anatomy and clinical assessment. The HA coating aids stability, but final placement and restoration decisions should be made by a qualified dental practitioner based on the patient’s specific needs.