FDA 510(k)

W&H Assistina Twin

N.º K: K171553 · 2017-12-08

Fecha de decisión2017-12-08

Código de productoEFB

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

W&H Assistina Twin is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K171553. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the W&H Assistina Twin?

W&H Assistina Twin is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K171553.

When did W&H Assistina Twin receive FDA 510(k) clearance?

W&H Assistina Twin received FDA 510(k) clearance on 2017-12-08, under 510(k) number K171553.

Who is the listed applicant for W&H Assistina Twin?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for W&H Assistina Twin?

The FDA product code for W&H Assistina Twin is EFB.

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Dispositivos relacionados (Código: EFB)

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Fuente oficial

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