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Dentsply Sirona

FDA 510(k) & PMA Approved Devices — 65 products

Total Devices65
Categories23
Latest Approval2026-04-23
TypeNumberDevice NameCodeDate
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
510(k) K211225 MIS Ti-base abutment NHA 2021-07-28 View
510(k) K210886 MIS Lance+ Conical Connection Dental Implant System DZE 2021-06-17 View
510(k) K202629 Dentsply Sirona Universal Spray Glazes EIH 2021-01-20 View
510(k) K200102 MIS Dental Implant System DZE 2020-09-03 View
510(k) K193405 Simplant Digital Guide NDP 2020-09-02 View
510(k) K200191 Sirona Dental CAD/CAM System with InLab Software PNP 2020-08-19 View
510(k) K193408 Sirona Dental CAD/CAM System with CEREC Chairside Software NHA 2020-08-16 View
510(k) K191152 MIS Ti-base Abutment NHA 2020-07-06 View
510(k) K201140 Axeos OAS 2020-06-22 View
510(k) K193078 MIS CONNECT Conical Connection System NHA 2020-03-25 View
510(k) K193529 ATLANTIS Abutment for MIS Conical Connection Implants NHA 2020-03-05 View
510(k) K192530 Surefil one Self-adhesive Composite Hybrid EMA 2020-01-23 View
510(k) K192409 Midwest Rhino XE and Air Motor M EFB 2020-01-13 View
510(k) K190977 Navina Smart System, Navina Classic System KNT 2019-11-22 View
510(k) K191865 SmartLite Pro Modular LED Curing Light EBZ 2019-11-20 View
510(k) K191806 Propex IQ Apex Locator LQY 2019-10-03 View
510(k) K190059 CEREC Guides NDP 2019-09-27 View
510(k) K191427 Halley resin system EBI 2019-08-26 View
510(k) K191616 Orthophos S OAS 2019-07-16 View
510(k) K190043 Halley resin EBI 2019-04-24 View
510(k) K182422 Lucitone Denture Base Materials EBI 2018-12-18 View
510(k) K182288 TPH Spectra ST Flowable Composite Restorative EBF 2018-11-20 View
510(k) K181520 Sirona Dental CAD/CAM System NHA 2018-10-11 View
510(k) K181476 Prime&Bond active Universal Adhesive KLE 2018-09-28 View
510(k) K181189 ATLANTIS Conus Structure NHA 2018-07-18 View
510(k) K172239 SIMPLANT 18 LLZ 2018-04-04 View
510(k) K180044 SIROLaser Blue GEX 2018-03-08 View
510(k) K171122 CEREC Ortho Software PNN 2018-01-11 View
510(k) K172225 Atlantis Abutment for MIS Implant NHA 2017-11-30 View
510(k) K170487 Navina Classic System KNT 2017-09-11 View
510(k) K163398 ATLANTIS suprastructures NHA 2017-08-14 View
510(k) K171115 3D Endo Software LLZ 2017-07-17 View
510(k) K170849 SIMPLANT Guide NDP 2017-06-15 View
510(k) K170500 SIROLaser Advance+ GEX 2017-05-16 View
510(k) K163350 Multibase Abutments EV and ATLANTIS Suprastructures NHA 2017-03-31 View
510(k) K162888 Cercon EIH 2017-02-24 View
510(k) K161213 XSmart iQ EBW 2017-02-10 View
510(k) K163155 MTM Clear Aligner NXC 2017-02-03 View
510(k) K161330 Pour Acrylic EBI 2016-10-06 View
510(k) K160825 MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology EKX 2016-09-27 View
510(k) K162107 TPH Spectra+ Universal Composite Restorative EBF 2016-09-27 View
510(k) K160626 ATLANTIS Abutment for HIOSSEN ET implant NHA 2016-08-29 View
510(k) K161030 ATLANTIS Abutment for CONELOG implant NHA 2016-08-26 View
510(k) K161269 CELTRA Press EIH 2016-08-12 View
510(k) K161118 SIMPLANT Online Case Review and SIMPLANT Editor LLZ 2016-07-28 View
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