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FDA 510(k)

SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT

K-Number: K013891 · 2002-02-05

ApplicantInstitut Straumann AG
Decision Date2002-02-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT 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 2002-02-05 under 510(k) number K013891. 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 SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT?

SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT is a medical device that received FDA 510(k) clearance on 2002-02-05. The listed applicant is Institut Straumann AG. The 510(k) number is K013891.

When did SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT receive FDA 510(k) clearance?

SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT received FDA 510(k) clearance on 2002-02-05, under 510(k) number K013891.

Who is the listed applicant for SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT?

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 SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT?

The FDA product code for SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT is DZE.

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Official Source

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