Opus Bulk Fill APS, Opus Bulk Fill Flow APS — Dentscare Ltda (510(k) K190758)
Opus Bulk Fill APS, Opus Bulk Fill Flow APS — Dentscare Ltda (510(k) K190758) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Opus Bulk Fill APS, Opus Bulk Fill Flow APS; Applicant: Dentscare Ltda; Clearance track: 510(k).
| Device name | Opus Bulk Fill APS, Opus Bulk Fill Flow APS |
|---|---|
| Applicant | Dentscare Ltda |
| Clearance track | 510(k) |
| Submission number | K190758 |
| Decision | Substantially Equivalent |
| Decision date | 2019-09-04 |
| Date received | 2019-03-25 |
| Product code | EBF |
| Device class | 2 |
| Medical specialty | Dental |
| Applicant location | BR |
| Source | openFDA device |
🔍 Search all device clearances →
$1999/mo
Try DeviceClear →