Dentsply Implants N V

FDA Filings

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

FDA Registration(s)

• Registration Number: 3007362683
• FEI Number: 3007362683
• Name: DENTSPLY Implants N.V.
• Owner & Operator: DENTSPLY SIRONA INC
• Contact Address: 221 WEST PHILADELPHIA ST. SUITE 60; York PA 17401 US
• Official Correspondent:
  • KARL NITTINGER
  • x-717-8494424-x
• US Agent:
  • Karl J Nittinger
  • Dentsply Sirona, Inc.
  • 717 8494424
  • karl.nittinger@dentsplysirona.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Research Campus 10 ; Hasselt Limburg, B-3500 BE
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006638827
• FEI Number: 3006638827
• Name: DENTSPLY Implants N.V.
• Owner & Operator: DENTSPLY SIRONA INC
• Contact Address: 221 WEST PHILADELPHIA ST. SUITE 60; York PA 17401 US
• Official Correspondent:
  • KARL NITTINGER
  • x-717-8494424-x
• US Agent:
  • Karl Nittinger
  • Dentsply Sirona, Inc.
  • 717 8494424
  • karl.nittinger@dentsplysirona.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Kolonel Begaultlaan 1b ; Leuven, 3012 BE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07392532181276 Dentsply Implants NV	SIMPLANT® 54500395IV	2020-03-05
GUDID 07392532208416 Dentsply Implants NV	Simplant 54500277V185	2019-05-03
GUDID 07392532206269 Dentsply Implants NV	Simplant 54500277P185	2019-05-03
GUDID 07392532209413 Dentsply Implants NV	Simplant 54500395IV31	2019-03-19
GUDID 07392532208423 Dentsply Implants NV	Simplant 54500394E31	2019-03-19
GUDID 07392532191251 Dentsply Implants NV	Simplant 54500277P18	2019-02-06
GUDID 07392532191220 Dentsply Implants NV	Simplant 54500277V18	2019-02-06
GUDID 07392532205583 Dentsply Implants NV	Simplant 54500395IV3	2018-10-19
GUDID 07392532204814 Dentsply Implants NV	Simplant 54500394E3	2018-10-19
GUDID 07392532177286 Dentsply Implants NV	SIMPLANT®	2018-07-06
GUDID 07392532177279 Dentsply Implants NV	SIMPLANT®	2018-07-06
GUDID 07392532178030 Dentsply Implants NV	SIMPLANT® 54500277A	2018-05-23
PMN K172239 | LLZ DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	SIMPLANT Software Platform	2018-04-10
GUDID 07392532181252 Dentsply Implants NV	SIMPLANT® 54500394E2	2018-03-29
PMN K163398 | NHA DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	ATLANTIS Suprastructures-Titanium & CoCr (AM)	2018-01-04
NDP DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	XiVE Surgical Kit Tray	2001-10-23
NDP DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	XiVE Surgical Kit Tray ExpertEase	2001-10-23
NDP DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	SIMPLANT Guide	2001-10-23
NDP DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	Accessories	2001-10-23
NDP DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	ANKYLOS Surgical Kit Tray Motor AB Reamer	2001-10-23
NDP DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	ANKYLOS Surgical Kit Tray ExpertEase	2001-10-23
NDP DENTSPLY Implants N.V. [DENTSPLY SIRONA INC]	ANKYLOS Surgical Kit Tray ABC	2001-10-23