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FDA 510(k)

P.0004 IMPLANTS

K-Number: K062129 · 2006-10-20

ApplicantInstitut Straumann AG
Decision Date2006-10-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P.0004 IMPLANTS 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 2006-10-20 under 510(k) number K062129. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.0004 IMPLANTS?

P.0004 IMPLANTS is a medical device that received FDA 510(k) clearance on 2006-10-20. The listed applicant is Institut Straumann AG. The 510(k) number is K062129.

When did P.0004 IMPLANTS receive FDA 510(k) clearance?

P.0004 IMPLANTS received FDA 510(k) clearance on 2006-10-20, under 510(k) number K062129.

Who is the listed applicant for P.0004 IMPLANTS?

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.0004 IMPLANTS?

The FDA product code for P.0004 IMPLANTS is DZE.

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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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