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FDA 510(k)

P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)

K-Number: K070478 · 2007-09-20

ApplicantStraumann Manufacturing, Inc.
Decision Date2007-09-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) is the device name listed in this FDA 510(k) record. The listed applicant is Straumann Manufacturing, Inc.. It received FDA 510(k) clearance on 2007-09-20 under 510(k) number K070478. 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 P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)?

P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) is a medical device that received FDA 510(k) clearance on 2007-09-20. The listed applicant is Straumann Manufacturing, Inc.. The 510(k) number is K070478.

When did P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) receive FDA 510(k) clearance?

P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) received FDA 510(k) clearance on 2007-09-20, under 510(k) number K070478.

Who is the listed applicant for P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)?

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

What is the FDA product code for P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)?

The FDA product code for P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) is NHA.

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Other records listing Straumann Manufacturing, 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.

K092814STRAUMANN DENTAL ABUTMENTSK090260MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTSK080239P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS

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

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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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