The following data is part of a premarket notification filed by Dentscare Ltda with the FDA for Orthocem, Ortho Bite.
| Device ID | K192682 |
| 510k Number | K192682 |
| Device Name: | Orthocem, Ortho Bite |
| Classification | Adhesive, Bracket And Tooth Conditioner, 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899633826582 | K192682 | 000 |