Straumann RN Gold Abutment for Bridge
510(k) K151590
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151590 | Date4 Mar 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Straumann USA
Questions
AI-generated answers, 19 Sep 2026
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.