FDA 510(k)

TRIOCLEAR System

N.º K: K193622 · 2021-07-06

SolicitantePerfection Aligner System Hong Kong Limited

Fecha de decisión2021-07-06

Código de productoNXC

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRIOCLEAR System is the device name listed in this FDA 510(k) record. The listed applicant is Perfection Aligner System Hong Kong Limited. It received FDA 510(k) clearance on 2021-07-06 under 510(k) number K193622. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TRIOCLEAR System?

TRIOCLEAR System is a medical device that received FDA 510(k) clearance on 2021-07-06. The listed applicant is Perfection Aligner System Hong Kong Limited. The 510(k) number is K193622.

When did TRIOCLEAR System receive FDA 510(k) clearance?

TRIOCLEAR System received FDA 510(k) clearance on 2021-07-06, under 510(k) number K193622.

Who is the listed applicant for TRIOCLEAR System?

The FDA 510(k) record lists Perfection Aligner System Hong Kong Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIOCLEAR System?

The FDA product code for TRIOCLEAR System is NXC.

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Fuente oficial

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