FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

86 results for "Dentsply Sirona"
73–86 of 86
Search insights Median review: 128d Cleared: 100% Top manufacturer: Dentsply Sirona Lead specialty: Dental
Cleared Jul 17, 2017
3D Endo Software
K171115 · LLZ
Dentsply Sirona
Radiology · 94d
Cleared Jun 15, 2017
SIMPLANT Guide
K170849 · NDP
Dentsply Sirona
Dental · 85d
Cleared May 16, 2017
SIROLaser Advance+
K170500 · GEX
Dentsply Sirona
General & Plastic Surgery · 84d
Cleared Mar 31, 2017
Multibase Abutments EV and ATLANTIS Suprastructures
K163350 · NHA
Dentsply Sirona
Dental · 121d
Cleared Feb 24, 2017
Cercon
K162888 · EIH
Dentsply Sirona
Dental · 130d
Cleared Feb 10, 2017
XSmart iQ
K161213 · EBW
Dentsply Sirona
Dental · 287d
Cleared Feb 03, 2017
MTM Clear Aligner
K163155 · NXC
Dentsply Sirona
Dental · 85d
Cleared Oct 06, 2016
Pour Acrylic
K161330 · EBI
Dentsply Sirona
Dental · 147d
Cleared Sep 27, 2016
TPH Spectra+ Universal Composite Restorative
K162107 · EBF
Dentsply Sirona
Dental · 60d
Cleared Sep 27, 2016
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
K160825 · EKX
Dentsply Sirona
Dental · 186d
Cleared Aug 29, 2016
ATLANTIS Abutment for HIOSSEN ET implant
K160626 · NHA
Dentsply Sirona
Dental · 175d
Cleared Aug 26, 2016
ATLANTIS Abutment for CONELOG implant
K161030 · NHA
Dentsply Sirona
Dental · 135d
Cleared Aug 12, 2016
CELTRA Press
K161269 · EIH
Dentsply Sirona
Dental · 99d
Cleared Jul 28, 2016
SIMPLANT Online Case Review and SIMPLANT Editor
K161118 · LLZ
Dentsply Sirona
Radiology · 99d