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Dentsply Sirona

65 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
DS Core CBCT Anatomy (K260785)Dentsply Sirona2026-04-23
Primevision 3D (K253959)Dentsply Sirona2026-02-05
Atlantis® Abutments in Titanium (K252343)Dentsply Sirona2025-12-09
CEREC Tessera Abutment System (K252248)Dentsply Sirona2025-11-26
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants (K251205)Dentsply Sirona2025-11-21
Dentsply Sirona Titanium Bases system (K250295)Dentsply Sirona2025-04-30
Atlantis® Abutments in Titanium (K250081)Dentsply Sirona2025-04-11
CEREC Cercon 4D CAD/CAM Blocks (K242462)Dentsply Sirona2024-10-24
Cercon® yo ML (K241557)Dentsply Sirona2024-08-28
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (K234018)Dentsply Sirona2024-05-07
Calibra Abutment Resin Cement (K240888)Dentsply Sirona2024-04-02
Washtrays (K231144)Dentsply Sirona2024-01-16
Lucitone Digital Print Denture System (K231578)Dentsply Sirona2023-10-20
SimPro™ Now, GentleCath™ Hydrophilic (K223756)Dentsply Sirona2023-05-04
PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) (K220841)Dentsply Sirona2022-11-16
OmniTaper EV Dental Implants, DS Implants abutments with EV connection (K221094)Dentsply Sirona2022-11-16
Surgical and Prosthetic Trays (K220791)Dentsply Sirona2022-05-03
MIS Angulated multi-unit abutments (K213432)Dentsply Sirona2022-04-01
LoFric Elle (K211212)Dentsply Sirona2022-02-17
DS Implants abutments provided with the EV connection (K213449)Dentsply Sirona2021-11-15
MIS Ti-base abutment (K211225)Dentsply Sirona2021-07-28
MIS Lance+ Conical Connection Dental Implant System (K210886)Dentsply Sirona2021-06-17
Dentsply Sirona Universal Spray Glazes (K202629)Dentsply Sirona2021-01-20
MIS Dental Implant System (K200102)Dentsply Sirona2020-09-03
Simplant Digital Guide (K193405)Dentsply Sirona2020-09-02
Sirona Dental CAD/CAM System with InLab Software (K200191)Dentsply Sirona2020-08-19
Sirona Dental CAD/CAM System with CEREC Chairside Software (K193408)Dentsply Sirona2020-08-16
MIS Ti-base Abutment (K191152)Dentsply Sirona2020-07-06
Axeos (K201140)Dentsply Sirona2020-06-22
MIS CONNECT Conical Connection System (K193078)Dentsply Sirona2020-03-25
ATLANTIS Abutment for MIS Conical Connection Implants (K193529)Dentsply Sirona2020-03-05
Surefil one Self-adhesive Composite Hybrid (K192530)Dentsply Sirona2020-01-23
Midwest Rhino XE and Air Motor M (K192409)Dentsply Sirona2020-01-13
Navina Smart System, Navina Classic System (K190977)Dentsply Sirona2019-11-22
SmartLite Pro Modular LED Curing Light (K191865)Dentsply Sirona2019-11-20
Propex IQ Apex Locator (K191806)Dentsply Sirona2019-10-03
CEREC Guides (K190059)Dentsply Sirona2019-09-27
Halley resin system (K191427)Dentsply Sirona2019-08-26
Orthophos S (K191616)Dentsply Sirona2019-07-16
Halley resin (K190043)Dentsply Sirona2019-04-24
Lucitone Denture Base Materials (K182422)Dentsply Sirona2018-12-18
TPH Spectra ST Flowable Composite Restorative (K182288)Dentsply Sirona2018-11-20
Sirona Dental CAD/CAM System (K181520)Dentsply Sirona2018-10-11
Prime&Bond active Universal Adhesive (K181476)Dentsply Sirona2018-09-28
ATLANTIS Conus Structure (K181189)Dentsply Sirona2018-07-18
SIMPLANT 18 (K172239)Dentsply Sirona2018-04-04
SIROLaser Blue (K180044)Dentsply Sirona2018-03-08
CEREC Ortho Software (K171122)Dentsply Sirona2018-01-11
Atlantis Abutment for MIS Implant (K172225)Dentsply Sirona2017-11-30
Navina Classic System (K170487)Dentsply Sirona2017-09-11
ATLANTIS suprastructures (K163398)Dentsply Sirona2017-08-14
3D Endo Software (K171115)Dentsply Sirona2017-07-17
SIMPLANT Guide (K170849)Dentsply Sirona2017-06-15
SIROLaser Advance+ (K170500)Dentsply Sirona2017-05-16
Multibase Abutments EV and ATLANTIS Suprastructures (K163350)Dentsply Sirona2017-03-31
Cercon (K162888)Dentsply Sirona2017-02-24
XSmart iQ (K161213)Dentsply Sirona2017-02-10
MTM Clear Aligner (K163155)Dentsply Sirona2017-02-03
Pour Acrylic (K161330)Dentsply Sirona2016-10-06
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology (K160825)Dentsply Sirona2016-09-27
TPH Spectra+ Universal Composite Restorative (K162107)Dentsply Sirona2016-09-27
ATLANTIS Abutment for HIOSSEN ET implant (K160626)Dentsply Sirona2016-08-29
ATLANTIS Abutment for CONELOG implant (K161030)Dentsply Sirona2016-08-26
CELTRA Press (K161269)Dentsply Sirona2016-08-12
SIMPLANT Online Case Review and SIMPLANT Editor (K161118)Dentsply Sirona2016-07-28

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Every clearance here is in the API, with alerts when new ones post.