Ambar, Ambar APS, Ambar Universal APS
FDA 510(k) K183424 · Dentscare Ltda
510(k) numberK183424
Submission
- Device name
- Ambar, Ambar APS, Ambar Universal APS
- Applicant
- Dentscare Ltda
Joinville, BR - Received
- December 11, 2018
- Decision date
- December 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ambar, Ambar APS, Ambar Universal APS cleared by the FDA?
Ambar, Ambar APS, Ambar Universal APS (K183424) received a 510(k) decision of Substantially Equivalent on December 13, 2019, 367 days after the submission was received.
What is the product code of K183424?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.