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FDA 510(k)

CERTAIN BELLATEK PROVISIONAL ABUTMENTS

K-Number: K130310 · 2013-06-21

ApplicantBiomet 3i
Decision Date2013-06-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERTAIN BELLATEK PROVISIONAL ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i. It received FDA 510(k) clearance on 2013-06-21 under 510(k) number K130310. 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 CERTAIN BELLATEK PROVISIONAL ABUTMENTS?

CERTAIN BELLATEK PROVISIONAL ABUTMENTS is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Biomet 3i. The 510(k) number is K130310.

When did CERTAIN BELLATEK PROVISIONAL ABUTMENTS receive FDA 510(k) clearance?

CERTAIN BELLATEK PROVISIONAL ABUTMENTS received FDA 510(k) clearance on 2013-06-21, under 510(k) number K130310.

Who is the listed applicant for CERTAIN BELLATEK PROVISIONAL ABUTMENTS?

The FDA 510(k) record lists Biomet 3i as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERTAIN BELLATEK PROVISIONAL ABUTMENTS?

The FDA product code for CERTAIN BELLATEK PROVISIONAL ABUTMENTS is NHA.

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Other records listing Biomet 3i 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.

K183138Certain BellaTek Express and BellaTek Flex AbutmentsK173374TSV BellaTek Encode Healing AbutmentsK170013Eztetic BellaTek Encode Healing AbutmentsK130949CP4 OSSEOTITE CERTAIN DENTAL IMPLANTSK122300T3 DENTAL IMPLANTK120776ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION

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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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