FDA 510(k)

JUVORA Dental Disc, Ceramill PEEK by JUVORA

N.º K: K160918 · 2017-02-13

SolicitanteJuvora

Fecha de decisión2017-02-13

Código de productoEBI

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

JUVORA Dental Disc, Ceramill PEEK by JUVORA is the device name listed in this FDA 510(k) record. The listed applicant is Juvora. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K160918. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the JUVORA Dental Disc, Ceramill PEEK by JUVORA?

JUVORA Dental Disc, Ceramill PEEK by JUVORA is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Juvora. The 510(k) number is K160918.

When did JUVORA Dental Disc, Ceramill PEEK by JUVORA receive FDA 510(k) clearance?

JUVORA Dental Disc, Ceramill PEEK by JUVORA received FDA 510(k) clearance on 2017-02-13, under 510(k) number K160918.

Who is the listed applicant for JUVORA Dental Disc, Ceramill PEEK by JUVORA?

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

What is the FDA product code for JUVORA Dental Disc, Ceramill PEEK by JUVORA?

The FDA product code for JUVORA Dental Disc, Ceramill PEEK by JUVORA is EBI.

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Fuente oficial

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