FDA 510(k)

StoneBite and StoneBite scan

Número K: K190571 · 2019-11-07

Data da decisão2019-11-07

Código do produtoELW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

StoneBite and StoneBite scan is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K190571. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the StoneBite and StoneBite scan?

StoneBite and StoneBite scan is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K190571.

When did StoneBite and StoneBite scan receive FDA 510(k) clearance?

StoneBite and StoneBite scan received FDA 510(k) clearance on 2019-11-07, under 510(k) number K190571.

Who is the listed applicant for StoneBite and StoneBite scan?

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

What is the FDA product code for StoneBite and StoneBite scan?

The FDA product code for StoneBite and StoneBite scan is ELW.

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Fonte oficial

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