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FDA 510(k)

Straumann CARES Screw-Retained Bridges and Bars

K-Number: K190097 · 2019-06-26

ApplicantInstitut Straumann AG
Decision Date2019-06-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann CARES Screw-Retained Bridges and Bars is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-06-26 under approval number K190097. 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 CARES Screw-Retained Bridges and Bars?

Straumann CARES Screw-Retained Bridges and Bars is a medical device that received FDA 510(k) clearance on 2019-06-26. It is manufactured by Institut Straumann AG. The 510(k) number is K190097.

When was Straumann CARES Screw-Retained Bridges and Bars approved by the FDA?

Straumann CARES Screw-Retained Bridges and Bars received FDA 510(k) clearance on 2019-06-26, under approval number K190097.

What company makes Straumann CARES Screw-Retained Bridges and Bars?

Straumann CARES Screw-Retained Bridges and Bars is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann CARES Screw-Retained Bridges and Bars?

The FDA product code for Straumann CARES Screw-Retained Bridges and Bars 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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