FDA 510(k)

Opus Bulk Fill APS, Opus Bulk Fill Flow APS

Número K: K190758 · 2019-09-04

Data da decisão2019-09-04

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Opus Bulk Fill APS, Opus Bulk Fill Flow APS is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K190758. 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 Opus Bulk Fill APS, Opus Bulk Fill Flow APS?

Opus Bulk Fill APS, Opus Bulk Fill Flow APS is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Dentscare Ltda. The 510(k) number is K190758.

When did Opus Bulk Fill APS, Opus Bulk Fill Flow APS receive FDA 510(k) clearance?

Opus Bulk Fill APS, Opus Bulk Fill Flow APS received FDA 510(k) clearance on 2019-09-04, under 510(k) number K190758.

Who is the listed applicant for Opus Bulk Fill APS, Opus Bulk Fill Flow APS?

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

What is the FDA product code for Opus Bulk Fill APS, Opus Bulk Fill Flow APS?

The FDA product code for Opus Bulk Fill APS, Opus Bulk Fill Flow APS is EBF.

Outros registros que listam Dentscare Ltda como candidato(a)

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Fonte oficial

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