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FDA 510(k)

GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP

K-Number: K083100 · 2008-11-19

ApplicantNobel Biocare USA, LLC
Decision Date2008-11-19
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare USA, LLC. It received FDA 510(k) clearance on 2008-11-19 under 510(k) number K083100. 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 GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP?

GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP is a medical device that received FDA 510(k) clearance on 2008-11-19. The listed applicant is Nobel Biocare USA, LLC. The 510(k) number is K083100.

When did GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP receive FDA 510(k) clearance?

GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP received FDA 510(k) clearance on 2008-11-19, under 510(k) number K083100.

Who is the listed applicant for GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP?

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

What is the FDA product code for GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP?

The FDA product code for GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP is NHA.

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Other records listing Nobel Biocare 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.

K110171NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMSK073142NOBELREPLACE HEXAGONAL IMPLANTK062566NOBELREPLACE TAPERED CONICAL CONNECTIONK052885ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315K050641ZYGOMA TIUNITEK043312NOBELRONDO DENTAL CERAMIC - ZIRCONIA

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K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

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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