FDA 510(k)

E-Dent 1000

Número K: K210977 · 2021-05-25

Data da decisão2021-05-25

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

E-Dent 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2021-05-25 under 510(k) number K210977. 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 E-Dent 1000?

E-Dent 1000 is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Envisiontec GmbH. The 510(k) number is K210977.

When did E-Dent 1000 receive FDA 510(k) clearance?

E-Dent 1000 received FDA 510(k) clearance on 2021-05-25, under 510(k) number K210977.

Who is the listed applicant for E-Dent 1000?

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

What is the FDA product code for E-Dent 1000?

The FDA product code for E-Dent 1000 is EBF.

Outros registros que listam Envisiontec GmbH como candidato(a)

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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