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FDA 510(k)

BellaTek Bars

K-Number: K260940 · 2026-09-21

ApplicantZimVie US Corp, LLC
Decision Date2026-09-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BellaTek Bars is the device name listed in this FDA 510(k) record. The listed applicant is ZimVie US Corp, LLC. It received FDA 510(k) clearance on 2026-09-21 under 510(k) number K260940. 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 BellaTek Bars?

BellaTek Bars is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is ZimVie US Corp, LLC. The 510(k) number is K260940.

When did BellaTek Bars receive FDA 510(k) clearance?

BellaTek Bars received FDA 510(k) clearance on 2026-09-21, under 510(k) number K260940.

Who is the listed applicant for BellaTek Bars?

The FDA 510(k) record lists ZimVie US Corp, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BellaTek Bars?

The FDA product code for BellaTek Bars is NHA.

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.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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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