FDA 510(k)

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head

Número K: K160410 · 2016-09-29

Data da decisão2016-09-29

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is the device name listed in this FDA 510(k) record. The listed applicant is Dental Savings Club. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K160410. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Dental Savings Club. The 510(k) number is K160410.

When did WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head receive FDA 510(k) clearance?

WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head received FDA 510(k) clearance on 2016-09-29, under 510(k) number K160410.

Who is the listed applicant for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

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

What is the FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head?

The FDA product code for WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head is EFB.

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