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Dentsply Sirona, Inc. FDA Approvals
0 new drug approvals and 19 device clearances on file. Matched by name to XRAY.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Surgical and Prosthetic Trays510(k)Sep 4, 2026General Hospital |
| SureSmile Aligner (ASSY500020)510(k)Apr 15, 2026Dental |
| SureSmile Software510(k)Mar 4, 2026Dental |
| Stainless Steel Surgical Kits510(k)Feb 6, 2026General Hospital |
| DS Core Detect510(k)Jan 7, 2026Radiology |
| Primescan 2510(k)Aug 29, 2025Dental |
| Motor and Apex Module (MaAM)510(k)Aug 25, 2025Dental |
| MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System510(k)Aug 21, 2025Dental |
| DS Core Diagnosis510(k)Aug 12, 2025Radiology |
| MIS LYNX Conical Connection Implant System510(k)Jul 24, 2025Dental |
| Plastic Surgical Kits510(k)Jul 22, 2025General Hospital |
| AH Plus Endodontic Sealer510(k)Feb 13, 2025Dental |
| Lucitone Digital Print Denture System510(k)Dec 17, 2024Dental |
| MIS LYNX Conical Connection Implant System510(k)Nov 25, 2024Dental |
| X-Smart Pro; X-Smart Pro+510(k)Jul 24, 2024Dental |
| Byte Aligner System510(k)Oct 18, 2023Dental |
| CEREC Tessera Abutment Block, CEREC Tessera Abutment System510(k)Mar 22, 2023Dental |
| Surgical Trays510(k)Mar 4, 2022General Hospital |
| PrimeTaper EV Dental Implant510(k)Aug 27, 2021Dental |