Medical Device Manufacturer · US , York , PA

Dentsply Sirona - FDA 510(k) Cleared Devices

65 submissions · 65 cleared · Since 2016
65
Total
65
Cleared
0
Denied
65 devices
26-50 of 65
Cleared Aug 19, 2020
Sirona Dental CAD/CAM System with InLab Software
K200191 · PNP
Dental · 205d
Cleared Aug 16, 2020
Sirona Dental CAD/CAM System with CEREC Chairside Software
K193408 · NHA
Dental · 251d
Cleared Jul 06, 2020
MIS Ti-base Abutment
K191152 · NHA
Dental · 432d
Cleared Jun 22, 2020
Axeos
K201140 · OAS
Radiology · 54d
Cleared Mar 25, 2020
MIS CONNECT Conical Connection System
K193078 · NHA
Dental · 141d
Cleared Mar 05, 2020
ATLANTIS Abutment for MIS Conical Connection Implants
K193529 · NHA
Dental · 76d
Cleared Jan 23, 2020
Surefil one Self-adhesive Composite Hybrid
K192530 · EMA
Dental · 129d
Cleared Jan 13, 2020
Midwest Rhino XE and Air Motor M
K192409 · EFB
Dental · 131d
Cleared Nov 22, 2019
Navina Smart System, Navina Classic System
K190977 · KNT
Gastroenterology & Urology · 221d
Cleared Nov 20, 2019
SmartLite Pro Modular LED Curing Light
K191865 · EBZ
Dental · 131d
Cleared Oct 03, 2019
Propex IQ Apex Locator
K191806 · LQY
Dental · 90d
Cleared Sep 27, 2019
CEREC Guides
K190059 · NDP
Dental · 259d
Cleared Aug 26, 2019
Halley resin system
K191427 · EBI
Dental · 89d
Cleared Jul 16, 2019
Orthophos S
K191616 · OAS
Radiology · 28d
Cleared Apr 24, 2019
Halley resin
K190043 · EBI
Dental · 105d
Cleared Dec 18, 2018
Lucitone Denture Base Materials
K182422 · EBI
Dental · 103d
Cleared Nov 20, 2018
TPH Spectra ST Flowable Composite Restorative
K182288 · EBF
Dental · 89d
Cleared Oct 11, 2018
Sirona Dental CAD/CAM System
K181520 · NHA
Dental · 122d
Cleared Sep 28, 2018
Prime&Bond active Universal Adhesive
K181476 · KLE
Dental · 115d
Cleared Jul 18, 2018
ATLANTIS Conus Structure
K181189 · NHA
Dental · 76d
Cleared Apr 04, 2018
SIMPLANT 18
K172239 · LLZ
Radiology · 252d
Cleared Mar 08, 2018
SIROLaser Blue
K180044 · GEX
General & Plastic Surgery · 59d
Cleared Jan 11, 2018
CEREC Ortho Software
K171122 · PNN
Dental · 269d
Cleared Nov 30, 2017
Atlantis Abutment for MIS Implant
K172225 · NHA
Dental · 128d
Cleared Sep 11, 2017
Navina Classic System
K170487 · KNT
Gastroenterology & Urology · 206d
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