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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VITTRA APS UNIQUE 97165187 not registered Live/Pending |
DENTSCARE LTDA. 2021-12-09 |