FDA 510(k)

Inman Digital Clear Aligners

Numéro K : K210763 · 2021-09-29

DemandeurInman Orthodontic Laboratories, Inc.

Date de décision2021-09-29

Code produitNXC

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Inman Digital Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Inman Orthodontic Laboratories, Inc.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K210763. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Inman Digital Clear Aligners?

Inman Digital Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Inman Orthodontic Laboratories, Inc.. The 510(k) number is K210763.

When did Inman Digital Clear Aligners receive FDA 510(k) clearance?

Inman Digital Clear Aligners received FDA 510(k) clearance on 2021-09-29, under 510(k) number K210763.

Who is the listed applicant for Inman Digital Clear Aligners?

The FDA 510(k) record lists Inman Orthodontic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inman Digital Clear Aligners?

The FDA product code for Inman Digital Clear Aligners is NXC.

Essais cliniques associés

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Dispositifs connexes (Code : NXC)

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Source officielle

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