Sirona Dental Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 2436911
• FEI Number: 1000521462
• Name: Sirona Dental, Inc.
• 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
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 30-30 47TH AVE., Suite 500 ; Long Island City, NY 11101 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

• Registration Number: 1064812
• FEI Number: 3003215343
• Name: SIRONA DENTAL, INC.
• 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
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 11000 S. Commerce Blvd. Suite K; CHARLOTTE, NC 28273 US

FDA Filings

Device Company	Device	Date
GUDID D764B10742051 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10742041 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10742031 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10742021 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10742011 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10741051 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10741041 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10741031 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10741021 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10741011 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10740501 SIRONA DENTAL, INC.	AimRight Holder	2022-12-15
GUDID D764B10731581 SIRONA DENTAL, INC.	Intraoral Sensor Holder	2022-12-15
GUDID D764B10731571 SIRONA DENTAL, INC.	Intraoral Sensor Holder	2022-12-15
GUDID D764B10731561 SIRONA DENTAL, INC.	Intraoral Sensor Holder	2022-12-15
GUDID D764B10731551 SIRONA DENTAL, INC.	Intraoral Sensor Holder	2022-12-15
GUDID D764B10731531 SIRONA DENTAL, INC.	Intraoral Sensor Holder	2022-12-15
GUDID D764B10731081 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B10731071 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B10731061 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B10731041 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B10731031 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B10731021 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B10731011 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B10731001 SIRONA DENTAL, INC.	Intraoral Sensor Holder Arms and Rings	2022-12-15
GUDID D764B10730621 SIRONA DENTAL, INC.	Universal Holders	2022-12-15
GUDID D764B02100001 SIRONA DENTAL, INC.	Intraoral Sensor Holders Arms and Rings	2022-12-15
GUDID D7641000053451 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D7641000053341 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D7641000053331 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D7641000053321 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D7641000053311 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D7641000053301 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D7641000053251 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D7641000053241 SIRONA DENTAL, INC.	AimRight	2022-12-15
GUDID D76464285491 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76464099601 SIRONA DENTAL, INC.	XIOS XG	2022-12-09
GUDID D76464099521 SIRONA DENTAL, INC.	XIOS XG	2022-12-09
GUDID D76464063051 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464062971 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464062891 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464062711 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464062631 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464062551 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464046491 SIRONA DENTAL, INC.	XIOS XG SUPREME	2022-12-09
GUDID D76464046311 SIRONA DENTAL, INC.	XIOS XG SUPREME	2022-12-09
GUDID D76464046231 SIRONA DENTAL, INC.	XIOS XG SUPREME	2022-12-09
GUDID D76464046151 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76464045991 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76464045321 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464045241 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464045161 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464044821 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464043831 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464043830 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464043670 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464042351 SIRONA DENTAL, INC.	SCHICK ELITE	2022-12-09
GUDID D76464041851 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76464041771 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76464022701 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464022621 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464022541 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464022471 SIRONA DENTAL, INC.	XIOS XG SUPREME	2022-12-09
GUDID D76464022391 SIRONA DENTAL, INC.	XIOS XG SUPREME	2022-12-09
GUDID D76464022211 SIRONA DENTAL, INC.	XIOS XG SUPREME	2022-12-09
GUDID D76464022131 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464022051 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464021971 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464021891 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76464021631 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76464021551 SIRONA DENTAL, INC.	XIOS XG WIFI	2022-12-09
GUDID D76464021481 SIRONA DENTAL, INC.	XIOS XG SELECT	2022-12-09
GUDID D76462243441 SIRONA DENTAL, INC.	XIOS+	2022-12-09
GUDID D76462017631 SIRONA DENTAL, INC.	XIOS+	2022-12-09
GUDID D76462017551 SIRONA DENTAL, INC.	XIOS+	2022-12-09
GUDID D76461490041 SIRONA DENTAL, INC.	XIOS	2022-12-09
GUDID D76461489981 SIRONA DENTAL, INC.	XIOS	2022-12-09
GUDID D76461443771 SIRONA DENTAL, INC.	XIOS	2022-12-09
GUDID D76461443511 SIRONA DENTAL, INC.	XIOS	2022-12-09
GUDID D76461442861 SIRONA DENTAL, INC.	XIOS	2022-12-09
GUDID D76461442781 SIRONA DENTAL, INC.	XIOS	2022-12-09
GUDID D7641000064651 SIRONA DENTAL, INC.	Intraoral Sensor Wallbox	2022-12-09
GUDID D7641000064580 SIRONA DENTAL, INC.	Intraoral Sensor Wallbox	2022-12-09
GUDID D7641000064571 SIRONA DENTAL, INC.	Intraoral Sensor Wallbox	2022-12-09
GUDID D7641000064561 SIRONA DENTAL, INC.	Intraoral Sensor Wallbox	2022-12-09
GUDID D7641000064510 SIRONA DENTAL, INC.	Intraoral Sensor Wallbox	2022-12-09
GUDID D7641000055741 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000055731 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000055721 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000055711 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000055701 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000055671 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000055651 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000054201 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000054191 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000054121 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000054111 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000054101 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000053931 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000053921 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09
GUDID D7641000053911 SIRONA DENTAL, INC.	FONA STELLARIS	2022-12-09

Related Finance Registrations

NCAGE Code	6VQF4	SIRONA DENTAL, INC.
CAGE Code	6VQF4	SIRONA DENTAL, INC.
S.A.M. Registration	6VQF4 [78613913]	SIRONA DENTAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090541001	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	DENTAL EQUIPMENT HS-CODE 940390, 850490 HBL BANQBRE4408582 . . . .	1 PKG
2020090451447	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	DENTAL EQUIPMENT HS-CODE 940390, 850490 HBL BANQBRE4408582 . . . .	1 PKG
2020082658806	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	DENTAL EQUIPMENT HS-CODE 940390, 850490 HBL BANQBRE4408582 . . . .	1 PKG
2020032544626	Anvers,Belgium -> Chester, Pennsylvania	DENTAL EQUIPMENT HS CODE 94036090	4 PKG
2019121168983	Anvers,Belgium -> Chester, Pennsylvania	DENTAL EQUIPMENT HS CODE 94036090	7 PKG
2019062923059	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	OTHER ARTICLES OF PLASTICS PARTS	100 CTN
201804192905	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	BATTERY HS85076000	1 CTN