Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sirona Dental Systems GmbH · Predicate Candidate Screening

42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

76 daysmedian FDA review time
198 days90th percentile
42clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160099CEREC SpeedGlazeSirona Dental Systems GmbH2016-06-021350
K151045TENEO Dental Treatment Unit and AccessoriesSirona Dental Systems GmbH2015-07-24950
K150909INTEGO Family and AccesoriesSirona Dental Systems GmbH2015-07-171050
K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH2015-07-021010
K150217ORTHOPHOS SLSirona Dental Systems GmbH2015-05-08980
K131319T1/T2/T3 TURBINE FAMILYSirona Dental Systems GmbH2014-05-303880
K132773SIDEXIS 4Sirona Dental Systems GmbH2013-12-11970
K123664INCORIS ZISirona Dental Systems GmbH2013-04-081310
K123952CEREC BLOCS C INSirona Dental Systems GmbH2013-03-20890
K123070GALILEOS FAMILYSirona Dental Systems GmbH2013-03-151650
K123545INCORIS TZISirona Dental Systems GmbH2013-02-01740
K111421SIRONA DENTAL CAD/CAM SYSTEMSirona Dental Systems GmbH2012-02-172730
K103711ORTHOPHOS XG 3D / CEPHSirona Dental Systems GmbH2011-03-22920
K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADEDSirona Dental Systems GmbH2011-02-15540
K100152SIRONA CAD/CAM SYSTEMSirona Dental Systems GmbH2010-10-222760
K092660SIROLASER ADVANCESirona Dental Systems GmbH2009-12-03970
K083344HELIODENT PLUSSirona Dental Systems GmbH2008-12-23400
K081903XIOS PLUS WALL-MODULESirona Dental Systems GmbH2008-08-26540
K080882CEREC OPTI SPRAYSirona Dental Systems GmbH2008-04-11110
K072107PERIOSCAN, MODEL: D 3496Sirona Dental Systems GmbH2008-02-141980
K062509INCORIS ZISirona Dental Systems GmbH2006-09-12150
K062506INCORIS ALSirona Dental Systems GmbH2006-09-08110
K060892GALILEOSSirona Dental Systems GmbH2006-04-14110
K052515SIROENDOSirona Dental Systems GmbH2006-03-311980
K053161SIROLASERSirona Dental Systems GmbH2006-01-18650
K051661IMPLANT HANDPIECESSirona Dental Systems GmbH2005-09-06760
K050354PERIOSCAN ULTRASONIC SCALERSirona Dental Systems GmbH2005-03-21350
K033812SIROAIR L AIR SCALERSirona Dental Systems GmbH2004-02-23760
K033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbH2004-01-15520
K033640SIROSON L AND SIROSONIC L ULTRASONIC SCALERSSirona Dental Systems GmbH2003-12-12220
K032543SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORSirona Dental Systems GmbH2003-11-14880
K033073ORTHOPHOS XG DS/CEPHSirona Dental Systems GmbH2003-10-10110
K031584SIROTORQUE LSirona Dental Systems GmbH2003-08-19900
K013650ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CDSirona Dental Systems GmbH2001-12-06300
K013659MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEMSirona Dental Systems GmbH2001-12-06300
K012517CEREC3 VITABLOCKSSirona Dental Systems GmbH2001-11-01870
K000672HELIODENT VARIOSirona Dental Systems GmbH2000-05-02640
K994172CEREC 3Sirona Dental Systems GmbH2000-02-08600
K992644SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEMSirona Dental Systems GmbH1999-08-23170
K990528ORTHOPHOS 3/3 CEPH/3 DSSirona Dental Systems GmbH1999-04-30700
K983242SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIESSirona Dental Systems GmbH1998-12-11860
K983057ORTHOPHOS 5/PLUS/CDSirona Dental Systems GmbH1998-10-22510

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda