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FDA 510(k)

ALTATEC CERAMIC ABUTMENT

K-Number: K032448 · 2003-08-22

ApplicantAltatec Biotechnologies
Decision Date2003-08-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALTATEC CERAMIC ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Altatec Biotechnologies. It received FDA 510(k) clearance on 2003-08-22 under 510(k) number K032448. 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 ALTATEC CERAMIC ABUTMENT?

ALTATEC CERAMIC ABUTMENT is a medical device that received FDA 510(k) clearance on 2003-08-22. The listed applicant is Altatec Biotechnologies. The 510(k) number is K032448.

When did ALTATEC CERAMIC ABUTMENT receive FDA 510(k) clearance?

ALTATEC CERAMIC ABUTMENT received FDA 510(k) clearance on 2003-08-22, under 510(k) number K032448.

Who is the listed applicant for ALTATEC CERAMIC ABUTMENT?

The FDA 510(k) record lists Altatec Biotechnologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALTATEC CERAMIC ABUTMENT?

The FDA product code for ALTATEC CERAMIC ABUTMENT is NHA.

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Other records listing Altatec Biotechnologies 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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