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FDA 510(k)

TSV BellaTek Encode Healing Abutments

K-Number: K173374 · 2017-12-13

ApplicantBiomet 3i
Decision Date2017-12-13
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TSV BellaTek Encode Healing 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 2017-12-13 under 510(k) number K173374. 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 TSV BellaTek Encode Healing Abutments?

TSV BellaTek Encode Healing Abutments is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Biomet 3i. The 510(k) number is K173374.

When did TSV BellaTek Encode Healing Abutments receive FDA 510(k) clearance?

TSV BellaTek Encode Healing Abutments received FDA 510(k) clearance on 2017-12-13, under 510(k) number K173374.

Who is the listed applicant for TSV BellaTek Encode Healing 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 TSV BellaTek Encode Healing Abutments?

The FDA product code for TSV BellaTek Encode Healing 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.

K251660T3 Pro Implants– ZimVie Packaging SystemK241753Immediate Molar ImplantsK241032BellaTek BarsK220978TSX ImplantsK213672T3 Pro ImplantsK212730BellaTek Encode Emergence Healing Abutments

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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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