Dentsply Sirona
Dentsply Sirona appears in FDA public data with 0 recalls, 88 510(k) clearances, 8 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on September 4, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 88
- Inspections
- 8
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261935 | Surgical and Prosthetic Trays | September 4, 2026 |
| K262127 | DS Core CBCT Anatomy | August 21, 2026 |
| K260785 | DS Core CBCT Anatomy | April 23, 2026 |
| K260722 | SureSmile Aligner (ASSY500020) | April 15, 2026 |
| K253565 | SureSmile Software | March 4, 2026 |
| K251614 | Stainless Steel Surgical Kits | February 6, 2026 |
| K253959 | Primevision 3D | February 5, 2026 |
| K253009 | DS Core Detect | January 7, 2026 |
| K252343 | Atlantis® Abutments in Titanium | December 9, 2025 |
| K252248 | CEREC Tessera Abutment System | November 26, 2025 |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | November 21, 2025 |
| K250771 | Primescan 2 | August 29, 2025 |
| K251811 | Motor and Apex Module (MaAM) | August 25, 2025 |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, M | August 21, 2025 |
| K250755 | DS Core Diagnosis | August 12, 2025 |
| K251297 | MIS LYNX Conical Connection Implant System | July 24, 2025 |
| K251300 | Plastic Surgical Kits | July 22, 2025 |
| K250295 | Dentsply Sirona Titanium Bases system | April 30, 2025 |
| K250081 | Atlantis® Abutments in Titanium | April 11, 2025 |
| K243546 | AH Plus Endodontic Sealer | February 13, 2025 |