Dentsply Sirona
FDA 510(k) & PMA Approved Devices — 65 products
Total Devices65
Categories23
Latest FDA decision2026-04-23
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260785 | DS Core CBCT Anatomy | QIH | 2026-04-23 | View |
| 510(k) | K253959 | Primevision 3D | OAS | 2026-02-05 | View |
| 510(k) | K252343 | Atlantis® Abutments in Titanium | NHA | 2025-12-09 | View |
| 510(k) | K252248 | CEREC Tessera Abutment System | NHA | 2025-11-26 | View |
| 510(k) | K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | NHA | 2025-11-21 | View |
| 510(k) | K250295 | Dentsply Sirona Titanium Bases system | NHA | 2025-04-30 | View |
| 510(k) | K250081 | Atlantis® Abutments in Titanium | NHA | 2025-04-11 | View |
| 510(k) | K242462 | CEREC Cercon 4D CAD/CAM Blocks | EIH | 2024-10-24 | View |
| 510(k) | K241557 | Cercon® yo ML | EIH | 2024-08-28 | View |
| 510(k) | K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System | NHA | 2024-05-07 | View |
| 510(k) | K240888 | Calibra Abutment Resin Cement | EMA | 2024-04-02 | View |
| 510(k) | K231144 | Washtrays | KCT | 2024-01-16 | View |
| 510(k) | K231578 | Lucitone Digital Print Denture System | EBI | 2023-10-20 | View |
| 510(k) | K223756 | SimPro™ Now, GentleCath™ Hydrophilic | EZD | 2023-05-04 | View |
| 510(k) | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | DZE | 2022-11-16 | View |
| 510(k) | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | DZE | 2022-11-16 | View |
| 510(k) | K220791 | Surgical and Prosthetic Trays | KCT | 2022-05-03 | View |
| 510(k) | K213432 | MIS Angulated multi-unit abutments | NHA | 2022-04-01 | View |
| 510(k) | K211212 | LoFric Elle | EZD | 2022-02-17 | View |
| 510(k) | K213449 | DS Implants abutments provided with the EV connection | NHA | 2021-11-15 | View |
No matching devices.
Page 1 of 4