The following data is part of a premarket notification filed by Dentscare Ltda with the FDA for Ambar, Ambar Aps, Ambar Universal Aps.
| Device ID | K183424 |
| 510k Number | K183424 |
| Device Name: | Ambar, Ambar APS, Ambar Universal APS |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DentsCare LTDA Av. Edgar Nilson Meister, 474 Joinville, BR 89219-501 |
| Contact | Roberta Uyara |
| Correspondent | Rodrigo Abreu United Regulatory LLC 12343 NW 25th St Coral Springs, FL 33065 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-11 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899633815944 | K183424 | 000 |
| 07899633815913 | K183424 | 000 |
| 07899633816552 | K183424 | 000 |