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FDA 510(k)

PROCERA PREPARABLE ABUTMENT SYSTEM

K-Number: K974150 · 1998-01-23

ApplicantNobel Biocare Uas, Inc.
Decision Date1998-01-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROCERA PREPARABLE ABUTMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Uas, Inc.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K974150. 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 PROCERA PREPARABLE ABUTMENT SYSTEM?

PROCERA PREPARABLE ABUTMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Nobel Biocare Uas, Inc.. The 510(k) number is K974150.

When did PROCERA PREPARABLE ABUTMENT SYSTEM receive FDA 510(k) clearance?

PROCERA PREPARABLE ABUTMENT SYSTEM received FDA 510(k) clearance on 1998-01-23, under 510(k) number K974150.

Who is the listed applicant for PROCERA PREPARABLE ABUTMENT SYSTEM?

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

What is the FDA product code for PROCERA PREPARABLE ABUTMENT SYSTEM?

The FDA product code for PROCERA PREPARABLE ABUTMENT SYSTEM is NHA.

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Other records listing Nobel Biocare Uas, Inc. as applicant

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K050444NOBELREPLACE ADAPTER, MODEL 32412K042658PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSK041876NOBELDIRECT OD IMPLANTK041312NOBELRONDO DENTAL CERAMIC-ALUMINAK041275PROCERA ABUTMENT OCTAGON

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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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