FDA 510(k)

PRE-MILLED Abutment

Número K: K202269 · 2020-11-25

Data da decisão2020-11-25

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRE-MILLED Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Mit Global Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K202269. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PRE-MILLED Abutment?

PRE-MILLED Abutment is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Mit Global Co., Ltd.. The 510(k) number is K202269.

When did PRE-MILLED Abutment receive FDA 510(k) clearance?

PRE-MILLED Abutment received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202269.

Who is the listed applicant for PRE-MILLED Abutment?

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

What is the FDA product code for PRE-MILLED Abutment?

The FDA product code for PRE-MILLED Abutment is NHA.

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Fonte oficial

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