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Straumann RN Gold Abutment for Bridge

by Straumann USA, LLC

510(k) K151590

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 NumberK151590 Date4 Mar 2016ClearedStatusActive

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  • Withdrawn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
NHA
Device Class
Class II
Regulation
21 CFR Part 872.3630
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 Straumann RN Gold Abutment for Bridge is a prosthetic component for dental implant systems, consisting of a noble metal alloy (Ceramicor) abutment base and a polymer (POM) modeling aid. This customizable one-piece solution is designed for anterior zone esthetics in dental bridge applications.

The device is supplied with a modeling aid attached via friction fit, which is sacrificed during laboratory casting or soldering procedures. Available in various heights including 12.3mm and 14.1mm with straight angulation, the device is authorized under FDA 510K K151590 with product code NHA.

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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 materials are used in the Straumann RN Gold Abutment for Bridge?

    The Straumann RN Gold Abutment for Bridge consists of a noble metal alloy (Ceramicor) abutment base and a polymer (POM) modeling aid. The modeling aid is attached via friction fit and is sacrificed during laboratory procedures.

  • What heights are available for the Straumann RN Gold Abutment for Bridge?

    The Straumann RN Gold Abutment for Bridge is available in various heights including 12.3mm and 14.1mm with straight angulation, designed for anterior zone esthetics in dental bridge applications.

  • How is the modeling aid used in the Straumann RN Gold Abutment for Bridge?

    The modeling aid is attached to the abutment via friction fit and is sacrificed during laboratory casting or soldering procedures, allowing for customization of the dental bridge.

  • What is the regulatory route for the Straumann RN Gold Abutment for Bridge?

    The Straumann RN Gold Abutment for Bridge is authorized under FDA 510K K151590 with product code NHA, classified as substantially equivalent.