Melbourne, AU · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 2 | 2022-10-28 |
| EMA | Cement, Dental | Class II | Dental | 1 | 2022-08-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-07-20 | Class II | Ongoing | Z-2954-2026 | Dentsply Sirona Capsule Mixer Model No. 5546068 | — | Potential for electrical discharge from unit when unplugged. |