Allcem Veneer APS
Material, Tooth Shade, Resin
Dentscare Ltda
The following data is part of a premarket notification filed by Dentscare Ltda with the FDA for Allcem Veneer Aps.
Pre-market Notification Details
| Device ID | K191389 |
| 510k Number | K191389 |
| Device Name: | Allcem Veneer APS |
| 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 | 2019-05-24 |
| Decision Date | 2020-02-25 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899633825806 | K191389 | 000 |
| 07899633815234 | K191389 | 000 |
| 07899633815241 | K191389 | 000 |
| 07899633815258 | K191389 | 000 |
| 07899633815265 | K191389 | 000 |
| 07899633815272 | K191389 | 000 |
| 07899633825646 | K191389 | 000 |
| 07899633825653 | K191389 | 000 |
| 07899633825776 | K191389 | 000 |
| 07899633825783 | K191389 | 000 |
| 07899633825790 | K191389 | 000 |
| 07899633815227 | K191389 | 000 |
Trademark Results [Allcem Veneer APS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLCEM VENEER APS 88275185 not registered Live/Pending |
DENTSCARE LTDA. 2019-01-24 |
 ALLCEM VENEER APS 88275181 not registered Live/Pending |
DENTSCARE LTDA. 2019-01-24 |
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