FDA 510(k)

CompleClear Plastic Orthodontic Bracket and Wire Appliance

Numéro K : K150830 · 2016-08-26

Date de décision2016-08-26

Code produitDYW

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

CompleClear Plastic Orthodontic Bracket and Wire Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Oracrew. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K150830. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CompleClear Plastic Orthodontic Bracket and Wire Appliance?

CompleClear Plastic Orthodontic Bracket and Wire Appliance is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Oracrew. The 510(k) number is K150830.

When did CompleClear Plastic Orthodontic Bracket and Wire Appliance receive FDA 510(k) clearance?

CompleClear Plastic Orthodontic Bracket and Wire Appliance received FDA 510(k) clearance on 2016-08-26, under 510(k) number K150830.

Who is the listed applicant for CompleClear Plastic Orthodontic Bracket and Wire Appliance?

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

What is the FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance?

The FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance is DYW.

Essais cliniques associés

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Dispositifs connexes (Code : DYW)

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Source officielle

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