South Bend, IN, US · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 4 | 2026-03-11 |
| EMA | Cement, Dental | Class II | Dental | 1 | 2025-12-19 |
| MVL | Cord, Retraction | Unclassified | Unknown | 1 | 2025-09-24 |
| EBG | Crown And Bridge, Temporary, Resin | Class II | Dental | 1 | 2024-05-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-11 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | EBF | Class II | Dental |
| 2025-12-19 | K254063 | iCEM Universal Plus | EMA | Class II | Dental |
| 2025-09-24 | K243910 | Retraxil | MVL | Unclassified | Unknown |
| 2024-09-17 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | EBF | Class II | Dental |
| 2024-05-23 | K233868 | dima Print Teeth & Temp | EBG | Class II | Dental |
| 2023-09-07 | K230644 | Signum opaque F | EBF | Class II | Dental |
| 2022-04-21 | K220605 | Venus Bulk Flow ONE | EBF | Class II | Dental |