Ambar, Ambar APS, Ambar Universal APS— 510(k) K183424

Name: FDA 510(k) clearance K183424
Creator: U.S. Food and Drug Administration
Published: 2019-12-13

Substantially Equivalent

Dentscare Ltda

FDA 510(k) clearance K183424 for Ambar, Ambar APS, Ambar Universal APS, Substantially Equivalent on 2019-12-13. Applicant: Dentscare Ltda. Device class: 2.

Clearance details

Applicant: Dentscare Ltda
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2018-12-11
Decision date: 2019-12-13
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.