FDA.reportPublic FDA data

SIRONA DENTAL SYSTEMS GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96149773003719498SIRONA DENTAL SYSTEMS GMBH1N2026-01-01FABRIKSTRASSE 31 BENSHEIM Hesse DE D-64625

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
E27662291290SIDEXIS XG - SIDEXIS XG Basis-DVD+4962511670contact@dentsplysirona.com
E27664565320SIDEXIS 4 - SIDEXIS 4 Basis-DVD+4962511670contact@dentsplysirona.com
E27666182630Sidexis 4 - Sidexis Update+4962511670contact@dentsplysirona.com
E27667732580Sidexis 4 - Sidexis 4 V4.4+4962511670contact@dentsplysirona.com
E27667737871Sidexis 4 - Sidexis 4 (Full version) 4.4+4962511670contact@dentsplysirona.com
E27667755841Sidexis 4 - Sidexis 4 (Upgrade) 4.4+4962511670contact@dentsplysirona.com
E27667755921Sidexis 4 - Sidexis 4 (Update) 4.4+4962511670contact@dentsplysirona.com
E27668907712Single use sleeve Primescan Box - 6890771+4962511670contact@dentsplysirona.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2255591875185669K990528ORTHOPHOS 3/3 CEPH/3 DSMUH1999-04-30
2255591757030259K983183GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, PEFB1998-12-10
2255591281979485K983057ORTHOPHOS 5/PLUS/CDMUH1998-10-22
2255591624662197K972436T1 LINE DENTAL HANDPIECESEFB1997-09-22
2255591678064556K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CDEHD1997-09-12
2255591391750310K972168SIDEXIS DIGITAL RADIOGRAPHY SYSTEMEHD1997-09-05
2255591564124832K965238T1 CONTROL HIGH SPEED DENTAL HANDPIECEEFA1997-03-19
2255591117940818K963664DENTAL HANDPIECE AND ACCESSORYEFB1996-10-24
2255591878479165K960819HELIODENT DSEAP1996-03-29
2255591346017525K933455COMPUTED ORAL RADIOLOGY SYSTEMEAP1994-01-31
2255591079025175K895901VITA CEREC SET AND VITA CEREC BLOCSELW1992-01-17
2255591970993899K800735U-STYLE ADAPTEREGS1980-04-10
2255591288406864K792445MW STRAIGHT ATTACHMENTEGS1979-12-06
2255591218421444K792302LS-100EFB1979-11-27
2255591815258833K253959Primevision 3DOAS2026-02-05
2255591494124810K251811Motor and Apex Module (MaAM)EBW2025-08-25
2255591808190059K250771Primescan 2NTK2025-08-29
2255591966779089K250295Dentsply Sirona Titanium Bases systemNHA2025-04-30
2255591616511900K233865X-Smart Pro; X-Smart Pro+EKX2024-07-24
2255591844752359K232448FREEPRINT® splintmasterMQC2023-10-12
2255591395026813K201140AxeosOAS2020-06-22
2255591745065257K200273FREEPRINT tempEBG2020-10-27
2255591686110104K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareNHA2020-08-16
2255591197572721K192409Midwest Rhino XE and Air Motor MEFB2020-01-13
2255591577584439K191616Orthophos SOAS2019-07-16
2255591337136580K190059CEREC GuidesNDP2019-09-27
2255591354963608K181520Sirona Dental CAD/CAM SystemNHA2018-10-11
2255591975915482K180703VITA YZ ST and VITA YZ XTEIH2018-08-01
2255592039428220K180044SIROLaser BlueGEX2018-03-08
2255591199318987K171122CEREC Ortho SoftwarePNN2018-01-11
2255591241699270K170500SIROLaser Advance+GEX2017-05-16
2255591232515471K160099CEREC SpeedGlazeEIH2016-06-02
2255591783907764K152661HICAT AirLLZ2015-11-16
2255591857364421K151045TENEO Dental Treatment Unit and AccessoriesEIA2015-07-24
2255591395514157K150909INTEGO Family and AccesoriesEIA2015-07-17
2255591054402346K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayEGS2015-07-02
2255591598748403K150217ORTHOPHOS SLOAS2015-05-08
2255591576007661K133320SICAT FUNCTIONLLZ2014-02-25
2255591067392673K132953TIDISHEILDPEM2014-02-18
2255591018135329K132773SIDEXIS 4LLZ2013-12-11
2255591015816806K131319T1/T2/T3 TURBINE FAMILYEFB2014-05-30
2255591776759392K123952CEREC BLOCS C INEIH2013-03-20
2255591878861836K123664INCORIS ZIEIH2013-04-08
2255591557622179K123545INCORIS TZIEIH2013-02-01
2255591783731927K123070GALILEOS FAMILYOAS2013-03-15
2255591054802781K113263ARGES IMAGING CONTRAST SPRAYELW2011-11-14
2255591871286082K111421SIRONA DENTAL CAD/CAM SYSTEMNHA2012-02-17
2255591900249483K110768COMPUTED DENTAL RADIOGRAPHYMUH2011-04-20
2255591581097316K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASERGEX2011-02-15
2255591536126378K103723SICAT IMPLANT V1.2LLZ2011-05-20
2255591936375740K103711ORTHOPHOS XG 3D / CEPHOAS2011-03-22
2255592064337434K102128VITABLOCSEIH2010-08-11
2255591386076597K100152SIRONA CAD/CAM SYSTEMNHA2010-10-22
2255591216802856K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMEAP2009-11-30
2255591933592947K093090GALILEOS IMPLANT, VERSION 1.7LLZ2009-12-17
2255591539702504K083344HELIODENT PLUSEHD2008-12-23
2255591334490403K081903XIOS PLUS WALL-MODULEMUH2008-08-26
2255591186984748K080882CEREC OPTI SPRAYELW2008-04-11
2255591884590273K073319STATMATIC 31 HANDPIECE MAINTENANCE UNITEFB2008-02-04
2255591125142685K072134SCHICK COMPUTED ORAL RADIOLOGY SYSTEMMUH2007-11-02
2255591996519102K072107PERIOSCAN, MODEL: D 3496ELC2008-02-14
2255591932210720K071891STATIS DENTAL HANDPIECESEFB2007-09-13
2255591811846782K062509INCORIS ZIEIH2006-09-12
2255591841285367K062506INCORIS ALEIH2006-09-08
2255591164208232K062418K-SPRAY, MODEL 085-2715EFB2006-10-19
2255591457439250K061701HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)EFA2006-08-25
2255591753334514K060892GALILEOSMUH2006-04-14
2255591112831423K053161SIROLASERGEX2006-01-18
2255591154594180K052515SIROENDOEKX2006-03-31
2255591603841375K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131ELC2005-09-02
2255592043690897K051661IMPLANT HANDPIECESEKX2005-09-06
2255591968840081K050354PERIOSCAN ULTRASONIC SCALERELC2005-03-21
2255591935509269K040808MINI L.E.D. OEM MODULEEBZ2004-04-28
2255591126393185K033812SIROAIR L AIR SCALEREFB2004-02-23
2255591100254599K033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERKOJ2004-01-15
2255591584473099K033640SIROSON L AND SIROSONIC L ULTRASONIC SCALERSELC2003-12-12
2255591560494733K033073ORTHOPHOS XG DS/CEPHEHD2003-10-10
2255591658647359K031584SIROTORQUE LEBW2003-08-19
2255591962107110K013659MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEMMUH2001-12-06
2255591378239552K013650ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CDMUH2001-12-06
2255591621870955K011061SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11EGS2001-06-28
2255591926639818K000672HELIODENT VARIOEHD2000-05-02
2255591753496840
2255592062160221
2255591147812230
2255591184706287
2255591265198837
2255591380390155
2255591480216004
2255591523093412
2255591631845077
2255591674573742
2255591678722230
2255591689620610
2255591820166053
2255591840288821
2255592018329748
2255592046677122

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EFB102020-01-13
EIH82018-08-01
MUH82011-04-20
OAS72026-02-05
NHA52025-04-30
GEX52018-03-08
LLZ52015-11-16
EHD52008-12-23
EKX42024-07-24
EGS42015-07-02
ELC42008-02-14
ELW32011-11-14
EAP32009-11-30
EBW22025-08-25
EIA22015-07-24
EFA22006-08-25
NTK12025-08-29
MQC12023-10-12
EBG12020-10-27
NDP12019-09-27
PNN12018-01-11
PEM12014-02-18
EBZ12004-04-28
KOJ12004-01-15

PMN#

42 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next