FDA 510(k)

e-SDF

Número K: K240619 · 2024-03-06

Data da decisão2024-03-06

Código do produtoPHR

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

e-SDF is the device name listed in this FDA 510(k) record. The listed applicant is Kids-E-Dental Llp. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K240619. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the e-SDF?

e-SDF is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Kids-E-Dental Llp. The 510(k) number is K240619.

When did e-SDF receive FDA 510(k) clearance?

e-SDF received FDA 510(k) clearance on 2024-03-06, under 510(k) number K240619.

Who is the listed applicant for e-SDF?

The FDA 510(k) record lists Kids-E-Dental Llp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for e-SDF?

The FDA product code for e-SDF is PHR.

Dispositivos Relacionados (Código: PHR)

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.

K250222SDF ProBelport Company, Inc., Gingi-Pak K241041Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLC K240059FAgamin®Tedequim Srl K222459Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc.K222323Black DiamondElevate Oral Care, LLC K172047Riva StarSdi Limited

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.