FDA 510(k)

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono

N.º K: K171562 · 2018-04-13

Fecha de decisión2018-04-13

Código de productoELW

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-13 under 510(k) number K171562. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K171562.

When did Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono receive FDA 510(k) clearance?

Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono received FDA 510(k) clearance on 2018-04-13, under 510(k) number K171562.

Who is the listed applicant for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?

The FDA 510(k) record lists Dreve Dentamid GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono?

The FDA product code for Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono is ELW.

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Otros registros que enlistan a Dreve Dentamid GmbH como solicitante

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Fuente oficial

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