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FDA 510(k)

NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS

K-Number: K112259 · 2011-10-28

ApplicantNobel Biocare AB
Decision Date2011-10-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2011-10-28 under 510(k) number K112259. 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 NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS?

NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS is a medical device that received FDA 510(k) clearance on 2011-10-28. The listed applicant is Nobel Biocare AB. The 510(k) number is K112259.

When did NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS receive FDA 510(k) clearance?

NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS received FDA 510(k) clearance on 2011-10-28, under 510(k) number K112259.

Who is the listed applicant for NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS?

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

What is the FDA product code for NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS?

The FDA product code for NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS is NHA.

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Other records listing Nobel Biocare AB 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.

K253988LiteSet TraysK253999Universal 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 ScrewK252197Nobel Biocare S Series ImplantsK243834NobelZygoma TiUltra Implant systemK240346NobelProcera Zirconia Implant BridgeK233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

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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.

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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