FDA 510(k)

PINK CAD/CAM disc

Número K: K153546 · 2016-09-28

RequerentePolident D.O.O., Dental Products Industry

Data da decisão2016-09-28

Código do produtoEBI

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PINK CAD/CAM disc is the device name listed in this FDA 510(k) record. The listed applicant is Polident D.O.O., Dental Products Industry. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K153546. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PINK CAD/CAM disc?

PINK CAD/CAM disc is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Polident D.O.O., Dental Products Industry. The 510(k) number is K153546.

When did PINK CAD/CAM disc receive FDA 510(k) clearance?

PINK CAD/CAM disc received FDA 510(k) clearance on 2016-09-28, under 510(k) number K153546.

Who is the listed applicant for PINK CAD/CAM disc?

The FDA 510(k) record lists Polident D.O.O., Dental Products Industry as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PINK CAD/CAM disc?

The FDA product code for PINK CAD/CAM disc is EBI.

Dispositivos Relacionados (Código: EBI)

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Fonte oficial

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