K183424 is an FDA 510(k) clearance for the Ambar, Ambar APS, Ambar Universal APS. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on December 13, 2019, 367 days after receiving the submission on December 11, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K183424 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2018 |
| Decision Date | December 13, 2019 |
| Days to Decision | 367 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLE - Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |