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FDA 510(k)

Certain BellaTek Express and BellaTek Flex Abutments

K-Number: K183138 · 2019-07-02

ApplicantBiomet 3i
Decision Date2019-07-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Certain BellaTek Express and BellaTek Flex 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 2019-07-02 under 510(k) number K183138. 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 Express and BellaTek Flex Abutments?

Certain BellaTek Express and BellaTek Flex Abutments is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Biomet 3i. The 510(k) number is K183138.

When did Certain BellaTek Express and BellaTek Flex Abutments receive FDA 510(k) clearance?

Certain BellaTek Express and BellaTek Flex Abutments received FDA 510(k) clearance on 2019-07-02, under 510(k) number K183138.

Who is the listed applicant for Certain BellaTek Express and BellaTek Flex 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 Express and BellaTek Flex Abutments?

The FDA product code for Certain BellaTek Express and BellaTek Flex Abutments is NHA.

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.

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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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