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FDA 510(k)

Straumann CARES M-Series CAD/CAM System

K-Number: K171649 · 2018-02-22

ApplicantInstitut Straumann AG
Decision Date2018-02-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann CARES M-Series CAD/CAM System is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2018-02-22 under approval number K171649. 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 M-Series CAD/CAM System?

Straumann CARES M-Series CAD/CAM System is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Institut Straumann AG. The 510(k) number is K171649.

When was Straumann CARES M-Series CAD/CAM System approved by the FDA?

Straumann CARES M-Series CAD/CAM System received FDA 510(k) clearance on 2018-02-22, under approval number K171649.

What company makes Straumann CARES M-Series CAD/CAM System?

Straumann CARES M-Series CAD/CAM System is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann CARES M-Series CAD/CAM System?

The FDA product code for Straumann CARES M-Series CAD/CAM System is NHA.

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Other Devices by Institut Straumann AG

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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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