FDA 510(k) Applications Submitted by Dentsply Sirona

FDA 510(k) Number Submission Date Device Name Applicant
K220791 03/18/2022 Surgical and Prosthetic Trays Dentsply Sirona
K220841 03/23/2022 PrimeTaper EV Dental Implants ╪3.0, DS Implants abutments with EV connection (XS) Dentsply Sirona
K221094 04/14/2022 OmniTaper EV Dental Implants, DS Implants abutments with EV connection Dentsply Sirona
K213432 10/22/2021 MIS Angulated multi-unit abutments Dentsply Sirona
K213449 10/26/2021 DS Implants abutments provided with the EV connection Dentsply Sirona
K160626 03/07/2016 ATLANTIS Abutment for HIOSSEN ET implant DENTSPLY SIRONA
K170849 03/22/2017 SIMPLANT Guide Dentsply Sirona
K160825 03/25/2016 MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology DENTSPLY SIRONA
K161030 04/13/2016 ATLANTIS Abutment for CONELOG implant Dentsply Sirona
K161118 04/20/2016 SIMPLANT Online Case Review and SIMPLANT Editor DENTSPLY SIRONA
K161213 04/29/2016 XSmart iQ DENTSPLY SIRONA
K161269 05/05/2016 CELTRA Press DENTSPLY SIRONA
K161330 05/12/2016 Pour Acrylic Dentsply Sirona
K162107 07/29/2016 TPH Spectra+ Universal Composite Restorative DENTSPLY SIRONA
K163155 11/10/2016 MTM Clear Aligner DENTSPLY SIRONA
K190043 01/09/2019 Halley resin Dentsply Sirona
K200102 01/17/2020 MIS Dental Implant System Dentsply Sirona
K170487 02/17/2017 Navina Classic System Dentsply Sirona
K171115 04/14/2017 3D Endo Software Dentsply Sirona
K190977 04/15/2019 Navina Smart System, Navina Classic System Dentsply Sirona
K191152 05/01/2019 MIS Ti-base Abutment Dentsply Sirona
K181189 05/03/2018 ATLANTIS Conus Structure Dentsply Sirona
K191427 05/29/2019 Halley resin system Dentsply Sirona
K181476 06/05/2018 Prime&Bond active Universal Adhesive Dentsply Sirona
K191616 06/18/2019 Orthophos S Dentsply Sirona
K191806 07/05/2019 Propex IQ Apex Locator Dentsply Sirona
K191865 07/12/2019 SmartLite Pro Modular LED Curing Light Dentsply Sirona
K172225 07/25/2017 Atlantis Abutment for MIS Implant Dentsply Sirona
K172239 07/26/2017 SIMPLANT 18 Dentsply Sirona
K182288 08/23/2018 TPH Spectra ST Flowable Composite Restorative Dentsply Sirona
K192409 09/04/2019 Midwest Rhino XE and Air Motor M Dentsply Sirona
K182422 09/06/2018 Lucitone Denture Base Materials Dentsply Sirona
K202629 09/11/2020 Dentsply Sirona Universal Spray Glazes Dentsply Sirona
K192530 09/16/2019 Surefil one Self-adhesive Composite Hybrid Dentsply Sirona
K162888 10/17/2016 Cercon Dentsply Sirona
K193078 11/05/2019 MIS CONNECT Conical Connection System Dentsply Sirona
K163350 11/30/2016 Multibase Abutments EV and ATLANTIS Suprastructures DENTSPLY SIRONA
K163398 12/05/2016 ATLANTIS suprastructures Dentsply Sirona
K193405 12/09/2019 Simplant Digital Guide Dentsply Sirona
K193408 12/09/2019 Sirona Dental CAD/CAM System with CEREC Chairside Software Dentsply Sirona
K193529 12/20/2019 ATLANTIS Abutment for MIS Conical Connection Implants Dentsply Sirona
K180044 01/08/2018 SIROLaser Blue Dentsply Sirona
K210886 03/25/2021 MIS Lance+ Conical Connection Dental Implant System Dentsply Sirona
K190059 01/11/2019 CEREC Guides Dentsply Sirona
K200191 01/27/2020 Sirona Dental CAD/CAM System with InLab Software Dentsply Sirona
K170500 02/21/2017 SIROLaser Advance+ Dentsply Sirona
K171122 04/17/2017 CEREC Ortho Software Dentsply Sirona
K201140 04/29/2020 Axeos Dentsply Sirona
K181520 06/11/2018 Sirona Dental CAD/CAM System Dentsply Sirona
K223756 12/15/2022 SimProÖ Now, GentleCathÖ Hydrophilic Dentsply Sirona
K211212 04/23/2021 LoFric Elle Dentsply Sirona
K211225 04/23/2021 MIS Ti-base abutment Dentsply Sirona


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