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FDA 510(k)

OrangeCAD Med Abutments

K-Number: K253312 · 2025-12-23

Decision Date2025-12-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OrangeCAD Med Abutments is a medical device manufactured by Orangecad Med GmbH. It received FDA 510(k) clearance on 2025-12-23 under approval number K253312. 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 OrangeCAD Med Abutments?

OrangeCAD Med Abutments is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Orangecad Med GmbH. The 510(k) number is K253312.

When was OrangeCAD Med Abutments approved by the FDA?

OrangeCAD Med Abutments received FDA 510(k) clearance on 2025-12-23, under approval number K253312.

What company makes OrangeCAD Med Abutments?

OrangeCAD Med Abutments is manufactured by Orangecad Med GmbH.

What is the FDA product code for OrangeCAD Med Abutments?

The FDA product code for OrangeCAD Med Abutments is NHA.

Related Devices (Code: NHA)

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.