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FDA 510(k)

Straumann Screw-Retained Abutments

K-Number: K192401 · 2020-04-06

ApplicantStraumann USA, LLC
Decision Date2020-04-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann Screw-Retained Abutments is a medical device manufactured by Straumann USA, LLC. It received FDA 510(k) clearance on 2020-04-06 under approval number K192401. 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 Straumann Screw-Retained Abutments?

Straumann Screw-Retained Abutments is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Straumann USA, LLC. The 510(k) number is K192401.

When was Straumann Screw-Retained Abutments approved by the FDA?

Straumann Screw-Retained Abutments received FDA 510(k) clearance on 2020-04-06, under approval number K192401.

What company makes Straumann Screw-Retained Abutments?

Straumann Screw-Retained Abutments is manufactured by Straumann USA, LLC.

What is the FDA product code for Straumann Screw-Retained Abutments?

The FDA product code for Straumann Screw-Retained 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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