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FDA 510(k)

Straumann CARES P-Series CAD/CAM System

K-Number: K203750 · 2021-10-09

Decision Date2021-10-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann CARES P-Series CAD/CAM System is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2021-10-09 under approval number K203750. 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 P-Series CAD/CAM System?

Straumann CARES P-Series CAD/CAM System is a medical device that received FDA 510(k) clearance on 2021-10-09. It is manufactured by Institut Straumann AG. The 510(k) number is K203750.

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

Straumann CARES P-Series CAD/CAM System received FDA 510(k) clearance on 2021-10-09, under approval number K203750.

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

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

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

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

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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.