Opus Bulk Fill APS, Opus Bulk Fill Flow APS— 510(k) K190758

Substantially Equivalent

Dentscare Ltda

FDA 510(k) clearance K190758 for Opus Bulk Fill APS, Opus Bulk Fill Flow APS, Substantially Equivalent on 2019-09-04. Applicant: Dentscare Ltda.

Clearance details

Applicant: Dentscare Ltda
Product code: Code EBF
Advisory panel: Dental
Date received: 2019-03-25
Decision date: 2019-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Joinville, BR

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