Wellspect Healthcare A Division Of Dentsply Ih Ab

FDA Filings

This page includes the latest FDA filings for Wellspect Healthcare A Division Of Dentsply Ih Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009632672
FEI Number3009632672
NameWellspect Healthcare (a Division of DENTSPLY IH AB)
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 AddressAminogatan 1
Molndal Vastra Gotalands lan [SE-14], SE-43121 SE
Establishment Type
  • Manufacture Medical Device
  • Sterilize Medical Device for Another Party (Contract Sterilizer)



FDA Filings

Device
Company
DeviceDate
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Navina Classic2017-09-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Profile EV2013-11-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Profile EV2013-11-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Profile EV2013-11-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Profile EV2013-11-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Plus Implant (EV)2012-11-15
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
LoFric2011-12-16
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Implant2011-12-16
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
catheter2011-12-16
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
catheter2011-12-16
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray2001-10-23
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray ExpertEase2001-10-23
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
SIMPLANT Guide2001-10-23
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
Accessories2001-10-23
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray Motor AB Reamer2001-10-23
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ExpertEase2001-10-23
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ABC2001-10-23
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
MTM Premium Welcome Kit1997-06-27
Wellspect Healthcare (a Division of DENTSPLY IH AB) [DENTSPLY SIRONA INC]
MTM Premium Kit1997-06-27

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