Home / Companies / Sirona Dental Systems GmbH

Sirona Dental Systems GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K160099CEREC SpeedGlazeJune 2, 2016
K151045TENEO Dental Treatment Unit and AccessoriesJuly 24, 2015
K150909INTEGO Family and AccesoriesJuly 17, 2015
K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayJuly 2, 2015
K150217ORTHOPHOS SLMay 8, 2015
K131319T1/T2/T3 TURBINE FAMILYMay 30, 2014
K132773SIDEXIS 4December 11, 2013
K123664INCORIS ZIApril 8, 2013
K123952CEREC BLOCS C INMarch 20, 2013
K123070GALILEOS FAMILYMarch 15, 2013
K123545INCORIS TZIFebruary 1, 2013
K111421SIRONA DENTAL CAD/CAM SYSTEMFebruary 17, 2012
K103711ORTHOPHOS XG 3D / CEPHMarch 22, 2011
K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASERFebruary 15, 2011
K100152SIRONA CAD/CAM SYSTEMOctober 22, 2010
K092660SIROLASER ADVANCEDecember 3, 2009
K083344HELIODENT PLUSDecember 23, 2008
K081903XIOS PLUS WALL-MODULEAugust 26, 2008
K080882CEREC OPTI SPRAYApril 11, 2008
K072107PERIOSCAN, MODEL: D 3496February 14, 2008