FDA 510(k)

Young INFINITY Cordless Handpiece System

Número K: K171377 · 2018-08-20

RequerenteYoung Dental Manufacturing Co. 1, LLC

Data da decisão2018-08-20

Código do produtoEKX

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Young INFINITY Cordless Handpiece System is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 2018-08-20 under 510(k) number K171377. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Young INFINITY Cordless Handpiece System?

Young INFINITY Cordless Handpiece System is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K171377.

When did Young INFINITY Cordless Handpiece System receive FDA 510(k) clearance?

Young INFINITY Cordless Handpiece System received FDA 510(k) clearance on 2018-08-20, under 510(k) number K171377.

Who is the listed applicant for Young INFINITY Cordless Handpiece System?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Young INFINITY Cordless Handpiece System?

The FDA product code for Young INFINITY Cordless Handpiece System is EKX.

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Fonte oficial

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