The following data is part of a premarket notification filed by Dentscare Ltda with the FDA for Opus Bulk Fill Aps, Opus Bulk Fill Flow Aps.
| Device ID | K190758 |
| 510k Number | K190758 |
| Device Name: | Opus Bulk Fill APS, Opus Bulk Fill Flow 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 | 2019-03-25 |
| Decision Date | 2019-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899633816064 | K190758 | 000 |
| 07899633816057 | K190758 | 000 |
| 07899633816040 | K190758 | 000 |
| 07899633816033 | K190758 | 000 |
| 07899633816026 | K190758 | 000 |
| 07899633816019 | K190758 | 000 |