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FDA 510(k)

Bonafix TiBase

K-Number: K221673 · 2023-07-14

ApplicantZentek Medical, LLC
Decision Date2023-07-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bonafix TiBase is the device name listed in this FDA 510(k) record. The listed applicant is Zentek Medical, LLC. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K221673. 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 Bonafix TiBase?

Bonafix TiBase is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Zentek Medical, LLC. The 510(k) number is K221673.

When did Bonafix TiBase receive FDA 510(k) clearance?

Bonafix TiBase received FDA 510(k) clearance on 2023-07-14, under 510(k) number K221673.

Who is the listed applicant for Bonafix TiBase?

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

What is the FDA product code for Bonafix TiBase?

The FDA product code for Bonafix TiBase is NHA.

Other records listing Zentek Medical, LLC 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.

K251294Bonafix Implant AbutmentsK213677Bonafix 2 Plus

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

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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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