PrimmaArt— 510(k) K231859

Substantially Equivalent

Dentscare Ltda

FDA 510(k) clearance K231859 for PrimmaArt, Substantially Equivalent on 2024-11-26. Applicant: Dentscare Ltda. Device class: 2.

Clearance details

Applicant: Dentscare Ltda
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2023-06-23
Decision date: 2024-11-26
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.