Medical Device Manufacturer · US , York , PA

Dentsply Sirona - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 2016

Official Website

64

Total

64

Cleared

0

Denied

50 devices

26-50 of 50

Cleared Jan 13, 2020

Midwest Rhino XE and Air Motor M

Cleared Nov 20, 2019

SmartLite Pro Modular LED Curing Light

Cleared Oct 03, 2019

Propex IQ Apex Locator

Cleared Sep 27, 2019

Cleared Aug 26, 2019

Halley resin system

Cleared Apr 24, 2019

Cleared Dec 18, 2018

Lucitone Denture Base Materials

Cleared Nov 20, 2018

TPH Spectra ST Flowable Composite Restorative

Cleared Oct 11, 2018

Sirona Dental CAD/CAM System

Cleared Sep 28, 2018

Prime&Bond active Universal Adhesive

Cleared Jul 18, 2018

ATLANTIS Conus Structure

Cleared Jan 11, 2018

CEREC Ortho Software

Cleared Nov 30, 2017

Atlantis Abutment for MIS Implant

Cleared Aug 14, 2017

ATLANTIS suprastructures

Cleared Jun 15, 2017

Cleared Mar 31, 2017

Multibase Abutments EV and ATLANTIS Suprastructures

Cleared Feb 24, 2017

Cleared Feb 10, 2017

Cleared Feb 03, 2017

MTM Clear Aligner

Cleared Oct 06, 2016

Cleared Sep 27, 2016

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology

Cleared Sep 27, 2016

TPH Spectra+ Universal Composite Restorative

Cleared Aug 29, 2016

ATLANTIS Abutment for HIOSSEN ET implant

Cleared Aug 26, 2016

ATLANTIS Abutment for CONELOG implant

Cleared Aug 12, 2016