StoneBite and StoneBite scan— 510(k) K190571

Substantially Equivalent

Dreve Dentamid GmbH

FDA 510(k) clearance K190571 for StoneBite and StoneBite scan, Substantially Equivalent on 2019-11-07. Applicant: Dreve Dentamid GmbH. Device class: 2.

Clearance details

Applicant
Dreve Dentamid GmbH
Product code
Code ELW
Device class
Class 2
Regulation
21 CFR 872.3660
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Unna, DE
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