← Every applicant
Dentsply Sirona FDA Approvals
0 new drug approvals and 24 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 |
|---|
| DS Core CBCT Anatomy510(k)Aug 21, 2026Radiology |
| DS Core CBCT Anatomy510(k)Apr 23, 2026Radiology |
| Primevision 3D510(k)Feb 5, 2026Radiology |
| Atlantis® Abutments in Titanium510(k)Dec 9, 2025Dental |
| CEREC Tessera Abutment System510(k)Nov 26, 2025Dental |
| Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants510(k)Nov 21, 2025Dental |
| Dentsply Sirona Titanium Bases system510(k)Apr 30, 2025Dental |
| Atlantis® Abutments in Titanium510(k)Apr 11, 2025Dental |
| CEREC Cercon 4D CAD/CAM Blocks510(k)Oct 24, 2024Dental |
| Cercon® yo ML510(k)Aug 28, 2024Dental |
| CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System510(k)May 7, 2024Dental |
| Calibra Abutment Resin Cement510(k)Apr 2, 2024Dental |
| Washtrays510(k)Jan 16, 2024General Hospital |
| Lucitone Digital Print Denture System510(k)Oct 20, 2023Dental |
| SimPro Now, GentleCath Hydrophilic510(k)May 4, 2023Gastroenterology, Urology |
| OmniTaper EV Dental Implants, DS Implants abutments with EV connection510(k)Nov 16, 2022Dental |
| PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)510(k)Nov 16, 2022Dental |
| Surgical and Prosthetic Trays510(k)May 3, 2022General Hospital |
| MIS Angulated multi-unit abutments510(k)Apr 1, 2022Dental |
| LoFric Elle510(k)Feb 17, 2022Gastroenterology, Urology |
| DS Implants abutments provided with the EV connection510(k)Nov 15, 2021Dental |
| MIS Ti-base abutment510(k)Jul 28, 2021Dental |
| MIS Lance+ Conical Connection Dental Implant System510(k)Jun 17, 2021Dental |
| Dentsply Sirona Universal Spray Glazes510(k)Jan 20, 2021Dental |