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FDA 510(k)

ZYGOMA TIUNITE

K-Number: K050641 · 2005-04-07

ApplicantNobel Biocare USA, LLC
Decision Date2005-04-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZYGOMA TIUNITE is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare USA, LLC. It received FDA 510(k) clearance on 2005-04-07 under 510(k) number K050641. 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 ZYGOMA TIUNITE?

ZYGOMA TIUNITE is a medical device that received FDA 510(k) clearance on 2005-04-07. The listed applicant is Nobel Biocare USA, LLC. The 510(k) number is K050641.

When did ZYGOMA TIUNITE receive FDA 510(k) clearance?

ZYGOMA TIUNITE received FDA 510(k) clearance on 2005-04-07, under 510(k) number K050641.

Who is the listed applicant for ZYGOMA TIUNITE?

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

What is the FDA product code for ZYGOMA TIUNITE?

The FDA product code for ZYGOMA TIUNITE is NHA.

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Other records listing Nobel Biocare USA, 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.

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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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