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ABUTMENT

by Steri-Oss, Inc.

510(k) K953836

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 NumberK953836 Date21 Sep 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  • Withdrawn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, 24 Sep 2026

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

An abutment is a dental device used to connect a dental implant to a prosthetic restoration such as a crown, bridge, or denture. It serves as the intermediary component that supports and retains the final restoration in the oral cavity.

This abutment is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the dental professional. It is manufactured by Steri-Oss, Inc. and received FDA 510(k) clearance (K953836) as substantially equivalent to a legally marketed device, with product code DZE and advisory committee classification in dental devices.

Other devices from Steri-Oss, Inc.

See all devices from Steri-Oss, Inc. →

Questions

AI-generated answers, 24 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 ABUTMENT used for?

    The ABUTMENT is a dental device that connects a dental implant to a prosthetic restoration such as a crown, bridge, or denture. It serves as the intermediary component that supports and retains the final restoration in the oral cavity, enabling proper function and aesthetics of the dental prosthesis.

  • How is the ABUTMENT supplied and is it sterile?

    The ABUTMENT is supplied non-sterile by Steri-Oss, Inc. It is not provided in a sterile condition and requires appropriate cleaning and sterilization by the dental professional before each use to ensure patient safety and prevent infection.

  • Can the ABUTMENT be reused, and what processing is required?

    Yes, the ABUTMENT is intended for reuse after appropriate cleaning and sterilization by the dental professional. It must be thoroughly cleaned and sterilized using validated methods between uses to maintain its integrity and ensure it is safe for subsequent patient applications.

  • What regulatory pathway was used for the ABUTMENT?

    The ABUTMENT received FDA 510(k) clearance (K953836) as substantially equivalent to a legally marketed device. It was evaluated under the traditional 510(k) pathway with product code DZE and reviewed by the Dental Devices advisory committee.