FDA 510(k)

CAPO BULK FILL

Número K: K152471 · 2016-08-04

Data da decisão2016-08-04

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

CAPO BULK FILL is the device name listed in this FDA 510(k) record. The listed applicant is Schuetz Dental GmbH. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K152471. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CAPO BULK FILL?

CAPO BULK FILL is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Schuetz Dental GmbH. The 510(k) number is K152471.

When did CAPO BULK FILL receive FDA 510(k) clearance?

CAPO BULK FILL received FDA 510(k) clearance on 2016-08-04, under 510(k) number K152471.

Who is the listed applicant for CAPO BULK FILL?

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

What is the FDA product code for CAPO BULK FILL?

The FDA product code for CAPO BULK FILL is EBF.

Dispositivos Relacionados (Código: EBF)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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