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FDA 510(k)

Straumann RN Gold Abutment for Bridge

K-Number: K151590 · 2016-03-04

ApplicantStraumann USA, LLC
Decision Date2016-03-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann RN Gold Abutment for Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K151590. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann RN Gold Abutment for Bridge?

Straumann RN Gold Abutment for Bridge is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Straumann USA, LLC. The 510(k) number is K151590.

When did Straumann RN Gold Abutment for Bridge receive FDA 510(k) clearance?

Straumann RN Gold Abutment for Bridge received FDA 510(k) clearance on 2016-03-04, under 510(k) number K151590.

Who is the listed applicant for Straumann RN Gold Abutment for Bridge?

The FDA 510(k) record lists Straumann USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann RN Gold Abutment for Bridge?

The FDA product code for Straumann RN Gold Abutment for Bridge is NHA.

Other records listing Straumann USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241575Straumann® Anatomic Healing Abutments XC (AHA)K203753Straumann Surgical CassettesK202942Straumann 4 mm Short ImplantsK192401Straumann Screw-Retained AbutmentsK190662MRI Compatibility for Existing Straumann Dental Implant SystemsK171784Straumann Dental Implant System

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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