Dentsply Ih Inc

FDA Filings

This page includes the latest FDA filings for Dentsply Ih Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1222802
FEI Number1000120733
NameDENTSPLY IH Inc.
Owner & OperatorDENTSPLY SIRONA INC
Contact Address221 WEST PHILADELPHIA ST. SUITE 60
York PA 17401 US
Official Correspondent
  • KARL NITTINGER
  • x-717-8494424-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address590 LINCOLN STREET
North Waltham, MA 02451 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
DENTSPLY IH, INC.
 MGUIDE® 2024-04-12
DENTSPLY IH, INC.
 MGUIDE® 2024-04-12
DENTSPLY IH, INC.
 MGUIDE® 2024-04-12
DENTSPLY IH, INC.
 MGUIDE® 2024-04-12
DENTSPLY IH, INC.
 MGUIDE® 2024-04-12
DENTSPLY IH, INC.
 MGUIDE® 2024-04-12
DENTSPLY IH, INC.
 MGUIDE® 2024-04-12
DENTSPLY IH, INC.
 ATLANTIS® 2024-04-12
DENTSPLY IH, INC.
 ATLANTIS® 2024-04-12
DENTSPLY IH, INC.
 DS 2022-04-05
DENTSPLY IH, INC.
 Atlantis 2021-08-24
DENTSPLY IH, INC.
 Atlantis 2020-08-18
DENTSPLY IH, INC.
 Atlantis® 2019-11-08
DENTSPLY IH, INC.
 Atlantis® 2019-11-08
DENTSPLY IH, INC.
 Atlantis® 2019-11-08
DENTSPLY IH, INC.
 Atlantis™ 2019-11-08
DENTSPLY IH, INC.
 Atlantis™ 2019-11-08
DENTSPLY IH, INC.
 Atlantis™ 2019-11-08
DENTSPLY IH, INC.
 Atlantis™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-11-08
DENTSPLY IH, INC.
 ATLANTIS™ 2019-03-04
DENTSPLY IH, INC.
 ATLANTIS™ 2019-03-04
DENTSPLY IH, INC.
 Simplant 54500277O182019-02-06
DENTSPLY IH, INC.
 SIMPLANT® 2018-11-22
DENTSPLY IH, INC.
 SIMPLANT® 2018-11-22
DENTSPLY IH, INC.
 SIMPLANT® 2018-11-22
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH, INC.
 ATLANTIS™ 2018-03-29
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ATLANTIS Suprastructures-Titanium & CoCr (AM)2018-01-04
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for MIS Implant2017-12-21
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment and Atlantis Abutment Screw2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ATLANTIS? Crown2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ATLANTIS? Conus Abutment for (Ti) NobelActive 3.02017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ATLANTIS? Abutment (Ti) for NobelActive 3.02017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ATLANTIS Abutment for NobelActive 3.02017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Straumann Bone Level Abutment2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment and Atlantis Crown Abutment in Zirconia for Keystone Genesis Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Plus Implant (EV)2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Camplig Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Crown Abutment in Zirconia2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for OsseoSpeed TX Profile Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Keystone Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Dentsply Ankylos Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Dentsply XiVE Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Nobel Biocare Active Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Nobel Replace Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment and Atlantis Abutment in Zirconia for Straumann Bone Level2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Astra Tech OsseoSpeed 3.0 Implant System2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for BioHorizons Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for BioHorizons Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for 3i Certain MicroMini Implants2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Implants2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Astra Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for 3i Certain Interface2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Nobel Replace2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for 3i Certain MicroMini Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for 3i MicroMini Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Nobel Replace Interface2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Zimmer Interface2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Zimmer Interface2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Astra Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for 3i Certain Implant2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment for Straumann Interface2017-10-27
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ATLANTIS? Abutment for Hiossen ET Implant2016-09-15
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Profile EV2013-11-20
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Profile EV2013-11-20
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Profile EV2013-11-20
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Profile EV2013-11-20
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Plus Implant (EV)2013-11-20
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Plus Implant (EV)2012-11-15
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2012-11-15
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)2012-11-15
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Abutment and Atlantis Crown Abutment in Zirconia for DENTSPLY Ankylos Implant2012-07-17
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Atlantis Temp Crown2006-08-17
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray2001-10-23
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
XiVE Surgical Kit Tray ExpertEase2001-10-23
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
SIMPLANT Guide2001-10-23
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
Accessories2001-10-23
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray Motor AB Reamer2001-10-23
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ExpertEase2001-10-23
DENTSPLY IH Inc. [DENTSPLY SIRONA INC]
ANKYLOS Surgical Kit Tray ABC2001-10-23

Related Finance Registrations
NCAGE Code5KA62DENTSPLY IH, INC.!DBA DENTSPLY IMPLANTS!DIV DBA/DENTSPLY IMPLANTS AND/OR!WELLSPECT HEALTHCARE
CAGE Code5KA62DENTSPLY IH, INC. DENTSPLY IMPLANTS DBA/DENTSPLY IMPLANTS AND/OR WELLSPECT HEALTHCARE
S.A.M. Registration5KA62 [847337201]DENTSPLY IH, INC. DENTSPLY IMPLANTS
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092656217Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT72 PKG
2020092656217Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT72 PKG
2020092656217Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT72 PKG
2020092526723Sines,Portugal -> Baltimore, MarylandHYDROPHILIC URINARY CATHETER11 CAS
2020092516044Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT48 PKG
2020092516044Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT48 PKG
2020091946398Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT24 PKG
2020091815123Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT24 PKG
2020091544110Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT48 PKG
2020091544110Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT48 PKG
2020090545212Gothenburg,Sweden -> Baltimore, MarylandMEDICAL EQUIPMENT24 PKG
202009024529Anvers,Belgium -> Baltimore, MarylandMEDICAL EQUIPMENT24 PKG
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