Dentsply Sirona, Inc.
FDA 510(k) & PMA Approved Devices — 21 products
Total Devices21
Categories12
Latest FDA decision2026-04-15
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260722 | SureSmile Aligner (ASSY500020) | NXC | 2026-04-15 | View |
| 510(k) | K253565 | SureSmile Software | PNN | 2026-03-04 | View |
| 510(k) | K251614 | Stainless Steel Surgical Kits | KCT | 2026-02-06 | View |
| 510(k) | K253009 | DS Core Detect | MYN | 2026-01-07 | View |
| 510(k) | K250771 | Primescan 2 | NTK | 2025-08-29 | View |
| 510(k) | K251811 | Motor and Apex Module (MaAM) | EBW | 2025-08-25 | View |
| 510(k) | K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | DZE | 2025-08-21 | View |
| 510(k) | K250755 | DS Core Diagnosis | QIH | 2025-08-12 | View |
| 510(k) | K251297 | MIS LYNX Conical Connection Implant System | DZE | 2025-07-24 | View |
| 510(k) | K251300 | Plastic Surgical Kits | KCT | 2025-07-22 | View |
| 510(k) | K243546 | AH Plus Endodontic Sealer | KIF | 2025-02-13 | View |
| 510(k) | K243336 | Lucitone Digital Print Denture™ System | EBI | 2024-12-17 | View |
| 510(k) | K241692 | MIS LYNX Conical Connection Implant System | DZE | 2024-11-25 | View |
| 510(k) | K233865 | X-Smart Pro; X-Smart Pro+ | EKX | 2024-07-24 | View |
| 510(k) | K230199 | Byte Aligner System | NXC | 2023-10-18 | View |
| 510(k) | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | NHA | 2023-03-22 | View |
| 510(k) | K212281 | Surgical Trays | KCT | 2022-03-04 | View |
| 510(k) | K210610 | PrimeTaper EV Dental Implant | DZE | 2021-08-27 | View |
| 510(k) | K193064 | Atlantis suprastructures | NHA | 2020-03-03 | View |
| 510(k) | K192149 | MIS Dental Implant System | DZE | 2019-12-11 | View |
No matching devices.
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