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FDA 510(k)

ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT

K-Number: K080164 · 2008-09-25

ApplicantZimmer Dental, Inc.
Decision Date2008-09-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Dental, Inc.. It received FDA 510(k) clearance on 2008-09-25 under 510(k) number K080164. 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 ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT?

ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Zimmer Dental, Inc.. The 510(k) number is K080164.

When did ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT receive FDA 510(k) clearance?

ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT received FDA 510(k) clearance on 2008-09-25, under 510(k) number K080164.

Who is the listed applicant for ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT?

The FDA 510(k) record lists Zimmer Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT?

The FDA product code for ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT is NHA.

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Other records listing Zimmer Dental, Inc. 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.

K160398MRI Compatibility for Existing Zimmer Dental Implant SystemsK132258ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEMK120873ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEMK121709ZFX DENTAL CAD SYSTEMK113753ZIMMER DENTAL TAPERED SCREW-VENT XK113092ZIMMER CONTOUR PROVISIONAL COPING

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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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