FDA 510(k)

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S

Número K: K222604 · 2023-04-21

Data da decisão2023-04-21

Código do produtoMQC

DecisãoSubstantially Equivalent

Resumo do dispositivo

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S is the device name listed in this FDA 510(k) record. The listed applicant is Dentona AG. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K222604. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S?

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Dentona AG. The 510(k) number is K222604.

When did dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S receive FDA 510(k) clearance?

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S received FDA 510(k) clearance on 2023-04-21, under 510(k) number K222604.

Who is the listed applicant for dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S?

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

What is the FDA product code for dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S?

The FDA product code for dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S is MQC.

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