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 |