FDA 510(k)

Keymill

Número K: K172764 · 2018-04-27

RequerenteMycone Dental Supply Company, Inc. (Aka Keystone Industries)

Data da decisão2018-04-27

Código do produtoEBI

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Keymill is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Company, Inc. (Aka Keystone Industries). It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K172764. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Keymill?

Keymill is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Mycone Dental Supply Company, Inc. (Aka Keystone Industries). The 510(k) number is K172764.

When did Keymill receive FDA 510(k) clearance?

Keymill received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172764.

Who is the listed applicant for Keymill?

The FDA 510(k) record lists Mycone Dental Supply Company, Inc. (Aka Keystone Industries) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Keymill?

The FDA product code for Keymill is EBI.

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Fonte oficial

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