FDA 510(k)

Clear Image Aligners

N.º K: K183643 · 2019-01-03

SolicitanteSpecialty Appliance Works, Inc.

Fecha de decisión2019-01-03

Código de productoNXC

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Clear Image Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Appliance Works, Inc.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K183643. 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 Clear Image Aligners?

Clear Image Aligners is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Specialty Appliance Works, Inc.. The 510(k) number is K183643.

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

Clear Image Aligners received FDA 510(k) clearance on 2019-01-03, under 510(k) number K183643.

Who is the listed applicant for Clear Image Aligners?

The FDA 510(k) record lists Specialty Appliance Works, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Image Aligners?

The FDA product code for Clear Image Aligners is NXC.

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Fuente oficial

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