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FDA 510(k)

Straumann RidgeFit Implants

K-Number: K211052 · 2021-07-08

Decision Date2021-07-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann RidgeFit Implants is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2021-07-08 under approval number K211052. 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 Straumann RidgeFit Implants?

Straumann RidgeFit Implants is a medical device that received FDA 510(k) clearance on 2021-07-08. It is manufactured by Institut Straumann AG. The 510(k) number is K211052.

When was Straumann RidgeFit Implants approved by the FDA?

Straumann RidgeFit Implants received FDA 510(k) clearance on 2021-07-08, under approval number K211052.

What company makes Straumann RidgeFit Implants?

Straumann RidgeFit Implants is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann RidgeFit Implants?

The FDA product code for Straumann RidgeFit Implants is DZE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.