FDA 510(k)

Mico One Orthodontic Screw

Número K: K202163 · 2022-10-07

Data da decisão2022-10-07

Código do produtoOAT

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mico One Orthodontic Screw is the device name listed in this FDA 510(k) record. The listed applicant is Ze Fang Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K202163. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mico One Orthodontic Screw?

Mico One Orthodontic Screw is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Ze Fang Technology Co., Ltd.. The 510(k) number is K202163.

When did Mico One Orthodontic Screw receive FDA 510(k) clearance?

Mico One Orthodontic Screw received FDA 510(k) clearance on 2022-10-07, under 510(k) number K202163.

Who is the listed applicant for Mico One Orthodontic Screw?

The FDA 510(k) record lists Ze Fang Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mico One Orthodontic Screw?

The FDA product code for Mico One Orthodontic Screw is OAT.

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