The following data is part of a premarket notification filed by Dentscare Ltda with the FDA for Allcem, Allcem Core.
| Device ID | K183465 |
| 510k Number | K183465 |
| Device Name: | Allcem, Allcem Core |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2019-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899633815210 | K183465 | 000 |
| 07899633815203 | K183465 | 000 |
| 07899633815197 | K183465 | 000 |
| 07899633815180 | K183465 | 000 |