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FDA 510(k)

SYNOCTA PROSTHETICS

K-Number: K990342 · 1999-07-20

ApplicantStraumann USA
Decision Date1999-07-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNOCTA PROSTHETICS is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 1999-07-20 under 510(k) number K990342. 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 PROSTHETICS?

SYNOCTA PROSTHETICS is a medical device that received FDA 510(k) clearance on 1999-07-20. The listed applicant is Straumann USA. The 510(k) number is K990342.

When did SYNOCTA PROSTHETICS receive FDA 510(k) clearance?

SYNOCTA PROSTHETICS received FDA 510(k) clearance on 1999-07-20, under 510(k) number K990342.

Who is the listed applicant for SYNOCTA PROSTHETICS?

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

What is the FDA product code for SYNOCTA PROSTHETICS?

The FDA product code for SYNOCTA PROSTHETICS is DZE.

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Official Source

View on FDA Database →

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