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FDA 510(k)

P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS

K-Number: K081005 · 2008-05-02

ApplicantInstitut Straumann AG
Decision Date2008-05-02
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K081005. 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 NC CARES TITANIUM AND CERAMIC ABUTMENTS?

P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Institut Straumann AG. The 510(k) number is K081005.

When did P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS receive FDA 510(k) clearance?

P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS received FDA 510(k) clearance on 2008-05-02, under 510(k) number K081005.

Who is the listed applicant for P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS?

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

What is the FDA product code for P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS?

The FDA product code for P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS is NHA.

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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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