FDA 510(k)

OrangeCAD Med Abutments

Numéro K : K253312 · 2025-12-23

Date de décision2025-12-23

Code produitNHA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

OrangeCAD Med Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Orangecad Med GmbH. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253312. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the OrangeCAD Med Abutments?

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

When did OrangeCAD Med Abutments receive FDA 510(k) clearance?

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

Who is the listed applicant for OrangeCAD Med Abutments?

The FDA 510(k) record lists Orangecad Med GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrangeCAD Med Abutments?

The FDA product code for OrangeCAD Med Abutments is NHA.

Essais cliniques associés

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Source officielle

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