FDA 510(k)

Duranext Abutments

Numéro K : K200355 · 2020-07-22

Date de décision2020-07-22

Code produitNHA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Duranext Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Elegant Dental Corp.. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K200355. 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 Duranext Abutments?

Duranext Abutments is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Elegant Dental Corp.. The 510(k) number is K200355.

When did Duranext Abutments receive FDA 510(k) clearance?

Duranext Abutments received FDA 510(k) clearance on 2020-07-22, under 510(k) number K200355.

Who is the listed applicant for Duranext Abutments?

The FDA 510(k) record lists Elegant Dental Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Duranext Abutments?

The FDA product code for Duranext Abutments is NHA.

Essais cliniques associés

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Dispositifs connexes (Code : NHA)

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Source officielle

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