Ambar, Ambar APS, Ambar Universal APS
K-Number: K183424 · 2019-12-13
ApplicantDentscare Ltda
Decision Date2019-12-13
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Ambar, Ambar APS, Ambar Universal APS is a medical device manufactured by Dentscare Ltda. It received FDA 510(k) clearance on 2019-12-13 under approval number K183424. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambar, Ambar APS, Ambar Universal APS?
Ambar, Ambar APS, Ambar Universal APS is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Dentscare Ltda. The 510(k) number is K183424.
When was Ambar, Ambar APS, Ambar Universal APS approved by the FDA?
Ambar, Ambar APS, Ambar Universal APS received FDA 510(k) clearance on 2019-12-13, under approval number K183424.
What company makes Ambar, Ambar APS, Ambar Universal APS?
Ambar, Ambar APS, Ambar Universal APS is manufactured by Dentscare Ltda.
What is the FDA product code for Ambar, Ambar APS, Ambar Universal APS?
The FDA product code for Ambar, Ambar APS, Ambar Universal APS is KLE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.