Sirona Dental Systems G M B H

FDA Filings

This page includes the latest FDA filings for Sirona Dental Systems G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9614977
FEI Number3003719498
NameSIRONA DENTAL SYSTEMS GMBH
Owner & OperatorDENTSPLY SIRONA INC
Contact Address221 WEST PHILADELPHIA ST. SUITE 60
York PA 17401 US
Official Correspondent
  • KARL NITTINGER
  • x-717-8494424-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFABRIKSTRASSE 31
BENSHEIM Hessen, D-64625 DE
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device



Registration Number9681851
FEI Number3002807009
NameSirona Dental Systems GmbH
Owner & OperatorDENTSPLY SIRONA INC
Contact Address221 WEST PHILADELPHIA ST. SUITE 60
York PA 17401 US
Official Correspondent
  • KARL NITTINGER
  • x-717-8494424-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFABRIKSTRASSE 31
Bensheim Hessen, D-64625 DE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
SIRONA Dental Systems GmbH
Primescan 2 2024-03-22
SIRONA Dental Systems GmbH
Primescan 2 2024-03-15
SIRONA Dental Systems GmbH
SiroRetro 2024-02-16
SIRONA Dental Systems GmbH
Midwest T2 Energo 68146722024-02-15
SIRONA Dental Systems GmbH
Midwest T2 Energo 68198202023-11-23
SIRONA Dental Systems GmbH
Midwest T1 Energo 68198122023-11-23
SIRONA Dental Systems GmbH
Midwest T1 Energo 68198042023-11-23
SIRONA Dental Systems GmbH
Midwest T1 Energo 68197962023-11-23
SIRONA Dental Systems GmbH
Midwest T1 Energo 68146982023-11-23
SIRONA Dental Systems GmbH
Midwest T1 Energo 68146802023-11-23
SIRONA Dental Systems GmbH
Midwest T2 Energo 68146642023-11-23
SIRONA Dental Systems GmbH
Midwest T2 Energo 68146562023-11-23
SIRONA Dental Systems GmbH
Sidexis 4 2023-10-18
SIRONA Dental Systems GmbH
Sidexis 4 2023-10-18
SIRONA Dental Systems GmbH
Sidexis 4 2023-10-18
SIRONA Dental Systems GmbH
Sidexis 4 2023-10-18
SIRONA Dental Systems GmbH
Midwest Diamonds 4714972023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714882023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714762023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714612023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714422023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714362023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714342023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714222023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714052023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4714002023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713922023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713712023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713672023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713652023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713642023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713632023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713612023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713562023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713512023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713492023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713472023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713452023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713312023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713292023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713212023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713192023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4713002023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712972023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712922023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712882023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712852023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712742023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712662023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712602023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712182023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4712052023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711982023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711882023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711852023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711672023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711642023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711572023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711382023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711272023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4711192023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4710872023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4710852023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4710822023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4710592023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4710332023-08-10
SIRONA Dental Systems GmbH
Midwest Diamonds 4710042023-08-10
SIRONA Dental Systems GmbH
T2 mini 64603852023-07-18
SIRONA Dental Systems GmbH
T2 Boost 66896292023-07-18
SIRONA Dental Systems GmbH
T1 mini 66894212023-07-18
SIRONA Dental Systems GmbH
T1 Boost 66893892023-07-18
SIRONA Dental Systems GmbH
CAD/CAM Software 68231112023-07-13
SIRONA Dental Systems GmbH
CAD/CAM Software 68231032023-07-13
SIRONA Dental Systems GmbH
Midwest Diamonds 4712932023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712912023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712902023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712892023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712552023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712312023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712142023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712082023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712032023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4712002023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711962023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711932023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711902023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711832023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711792023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711662023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711652023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711632023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711602023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711592023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711552023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711512023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4711442023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4710462023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4710422023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4710182023-07-06
SIRONA Dental Systems GmbH
Midwest Diamonds 4710172023-07-06
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Cerec Essentials Materials Starter Kit2017-12-22
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Celtra? Duo and Cerec? Zirconia Blocks & Materials Starter Kit2017-12-22
Sirona Dental Systems GmbH
CEREC SpeedGlaze2016-06-02
SIRONA DENTAL SYSTEMS GMBH
TENEO Dental Treatment Unit And Accessories2015-07-24
Sirona Dental Systems GMBH
INTEGO Family And Accesories2015-07-17
Sirona Dental Systems GMBH
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray2015-07-02
Sirona Dental Systems GMBH
ORTHOPHOS SL2015-05-08
SIRONA DENTAL SYSTEMS GMBH
T1/T2/T3 TURBINE FAMILY2014-05-30
SIRONA DENTAL SYSTEMS GMBH
SIDEXIS 42013-12-11
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Profile EV2013-11-20
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Profile EV2013-11-20
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Profile EV2013-11-20
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Profile EV2013-11-20
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
SIRONA DENTAL SYSTEMS GMBH
INCORIS ZI2013-04-08
SIRONA DENTAL SYSTEMS GMBH
CEREC BLOCS C IN2013-03-20
SIRONA DENTAL SYSTEMS GMBH
GALILEOS FAMILY2013-03-15
SIRONA DENTAL SYSTEMS GMBH
INCORIS TZI2013-02-01
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Plus Implant (EV)2012-11-15
SIRONA DENTAL SYSTEMS GMBH
SIRONA DENTAL CAD/CAM SYSTEM2012-02-17
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Implant2011-12-16
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Dental Abutment/Implant2011-12-16
SIRONA DENTAL SYSTEMS GMBH
ORTHOPHOS XG 3D / CEPH2011-03-22
SIRONA DENTAL SYSTEMS GMBH
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER2011-02-15
SIRONA DENTAL SYSTEMS GMBH
SIRONA CAD/CAM SYSTEM2010-10-22
SIRONA DENTAL SYSTEMS GMBH
SIROLASER ADVANCE2009-12-03
SIRONA DENTAL SYSTEMS GMBH
HELIODENT PLUS2008-12-23
SIRONA DENTAL SYSTEMS GMBH
CEREC OPTI SPRAY2008-04-11
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Cercon Abutments2008-03-28
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Ankylos Cercon Balance2008-03-28
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Straight Attachments2008-02-18
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Shorty Handpiece & Motor,2008-02-18
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Rhino Handpiece2008-02-18
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Midwest RDH2008-02-18
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Midwest Handpiece,2008-02-18
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Contra Angle Heads2008-02-18
SIRONA DENTAL SYSTEMS GMBH
PERIOSCAN, MODEL: D 34962008-02-14
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Ankylos Temporary Abutment Balance2008-02-13
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
EsthetiCap2008-01-22
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Ankylos Plus Dental Implant System2008-01-22
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
XiVe TG2008-01-22
SIRONA DENTAL SYSTEMS GMBH
INCORIS ZI2006-09-12
SIRONA DENTAL SYSTEMS GMBH
INCORIS AL2006-09-08
SIRONA DENTAL SYSTEMS GMBH
GALILEOS2006-04-14
SIRONA DENTAL SYSTEMS GMBH
SIROENDO2006-03-31
SIRONA DENTAL SYSTEMS GMBH
SIROLASER2006-01-18
SIRONA DENTAL SYSTEMS GMBH
IMPLANT HANDPIECES2005-09-06
SIRONA DENTAL SYSTEMS GMBH
PERIOSCAN ULTRASONIC SCALER2005-03-21
SIRONA DENTAL SYSTEMS GMBH
SIROAIR L AIR SCALER2004-02-23
SIRONA DENTAL SYSTEMS GMBH
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER2004-01-15
SIRONA DENTAL SYSTEMS GMBH
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS2003-12-12
SIRONA DENTAL SYSTEMS GMBH
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES2003-11-14
SIRONA DENTAL SYSTEMS GMBH
ORTHOPHOS XG DS/CEPH2003-10-10
SIRONA DENTAL SYSTEMS GMBH
SIROTORQUE L2003-08-19
SIRONA DENTAL SYSTEMS GMBH
MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM2001-12-06
SIRONA DENTAL SYSTEMS GMBH
ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD2001-12-06
SIRONA DENTAL SYSTEMS GMBH
CEREC3 VITABLOCKS2001-11-01
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray2001-10-23
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray ExpertEase2001-10-23
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
SIMPLANT Guide2001-10-23
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
Accessories2001-10-23
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray Motor AB Reamer2001-10-23
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ExpertEase2001-10-23
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ABC2001-10-23
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray2001-10-23
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray ExpertEase2001-10-23
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
SIMPLANT Guide2001-10-23
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
Accessories2001-10-23
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray Motor AB Reamer2001-10-23
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ExpertEase2001-10-23
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ABC2001-10-23
SIRONA DENTAL SYSTEMS GMBH
HELIODENT VARIO2000-05-02
SIRONA DENTAL SYSTEMS GMBH
CEREC 32000-02-08
SIRONA DENTAL SYSTEMS GMBH
SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM1999-08-23
SIRONA DENTAL SYSTEMS GMBH
ORTHOPHOS 3/3 CEPH/3 DS1999-04-30
SIRONA DENTAL SYSTEMS GMBH
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES1998-12-11
SIRONA DENTAL SYSTEMS GMBH
ORTHOPHOS 5/PLUS/CD1998-10-22
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
MTM Premium Welcome Kit1997-06-27
Sirona Dental Systems GmbH [DENTSPLY SIRONA INC]
MTM Premium Kit1997-06-27
SIRONA DENTAL SYSTEMS GMBH [DENTSPLY SIRONA INC]
DXTTR1996-05-01

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092352648Anvers,Belgium -> Chester, PennsylvaniaDENTAL EQUIPMENT HS CODE 90184990 73269098 94021000 39269097 94019080 9018499099 PKG
2020091745584Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyDENTAL EQUIPMENT HS-CODE 732690 HBL BANQBRE4405448 . . . .2 PKG
2020090541071Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyDENTAL EQUIPMENT HS-CODE 85365080 HBL BANQBRE4421535 . . . .17 PKG
2020090550570Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyDENTAL EQUIPMENT HS-CODE 732690 HBL BANQBRE4405448 . . . .2 PKG
2020090451476Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyDENTAL EQUIPMENT HS-CODE 85365080 HBL BANQBRE4421535 . . . .17 PKG
2020090283807Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyDENTAL EQUIPMENT HS-CODE 732690 HBL BANQBRE4405448 . . . .2 PKG
2020082650240Anvers,Belgium -> Chester, Pennsylvania36 PACKAGES DENTAL EQUIPMENT HS-CODE 9018499036 PKG
2020082650203Anvers,Belgium -> Chester, Pennsylvania36 PACKAGES DENTAL EQUIPMENT HS-CODE 9018499064 PKG
2020082650203Anvers,Belgium -> Chester, Pennsylvania28 PACKAGES DENTAL EQUIPMENT HS-CODE 9018499064 PKG

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