FDA 510(k)

SunClear Aligner system

N.º K: K190394 · 2019-12-16

Fecha de decisión2019-12-16

Código de productoNXC

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

SunClear Aligner system is the device name listed in this FDA 510(k) record. The listed applicant is Sun Dental Laboratories, LLC. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K190394. 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 SunClear Aligner system?

SunClear Aligner system is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Sun Dental Laboratories, LLC. The 510(k) number is K190394.

When did SunClear Aligner system receive FDA 510(k) clearance?

SunClear Aligner system received FDA 510(k) clearance on 2019-12-16, under 510(k) number K190394.

Who is the listed applicant for SunClear Aligner system?

The FDA 510(k) record lists Sun Dental Laboratories, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SunClear Aligner system?

The FDA product code for SunClear Aligner system is NXC.

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Fuente oficial

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