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

Name: FDA 510(k) clearance K190758
Creator: U.S. Food and Drug Administration
Published: 2019-09-04

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. Device class: 2.

Clearance details

Applicant: Dentscare Ltda
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2019-03-25
Decision date: 2019-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Joinville, BR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.