FDA 510(k)

CompleClear Plastic Orthodontic Bracket and Wire Appliance

N.º K: K150830 · 2016-08-26

SolicitanteOracrew

Fecha de decisión2016-08-26

Código de productoDYW

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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