Chicago, IL, US · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 2 | 2022-10-11 |
| EMA | Cement, Dental | Class II | Dental | 1 | 2024-07-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2023-07-20 | Class II | Ongoing | Z-0211-2024 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, M… | — | Reports were received the elastomer cup material is crumbling. |