The following data is part of a premarket notification filed by Dentscare Ltda with the FDA for Vittra Aps Unique.
| Device ID | K210231 |
| 510k Number | K210231 |
| Device Name: | Vittra APS Unique |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Dentscare Ltda Av. Edgar Nelson 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899633829330 | K210231 | 000 |
| 07899633829323 | K210231 | 000 |
| 07899633829316 | K210231 | 000 |
| 00304040169841 | K210231 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITTRA APS UNIQUE 97165187 not registered Live/Pending |
DENTSCARE LTDA. 2021-12-09 |