Opallis, Opallis Flow— 510(k) K201707

Substantially Equivalent

Dentscare Ltda

FDA 510(k) clearance K201707 for Opallis, Opallis Flow, Substantially Equivalent on 2020-12-22. 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: 2020-06-22
Decision date: 2020-12-22
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.