Dentsply Prosthetics

FDA Filings

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

FDA Registration(s)

• Registration Number: 2585114
• FEI Number: 2585114
• Name: DENTSPLY PROSTHETICS
• 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: 570 WEST COLLEGE AVENUE ; York, PA 17401 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Device in the United States for Export Only

• Registration Number: 2647456
• FEI Number: 2647456
• Name: DENTSPLY PROSTHETICS
• 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: RT. 183, KM. 19.6 ; Las Piedras, PR 00771 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K153590 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Lucitone 199	2018-02-13
PMN K153590 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Digital denture early experience kit	2018-02-13
PMN K161330 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Digital denture early experience kit	2016-10-24
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Overglaze	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Overglaze	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Incisal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Incisal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Body Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Universal Body Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Stain & Overglaze Kit	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Stain & Overglaze Kit	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Overglaze	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Overglaze	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Incisal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Incisal Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Body Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Dentsply Sirona Universal Body Stain	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Celtra Ceram	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Celtra Ceram	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	CELTRA Duo	2016-08-16
PMN K161269 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	CELTRA Duo	2016-08-16
PMN K123615 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Cerec Essentials Materials Starter Kit	2013-03-08
PMN K123615 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Celtra? Duo and Cerec? Zirconia Blocks & Materials Starter Kit	2013-03-08
PMN K091706 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Quattro Porcelain System	2009-08-31
PMN K091706 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Quattro Porcelain System	2009-08-31
PMN K964174 | KIF DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	ProRoot MTA Matl (root repair)	2009-05-13
PMN K080311 | EBG DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Radica	2008-04-21
PMN K080311 | EBD DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Radica	2008-04-21
PMN K920499 | ECB DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Sani-Tip	2008-03-06
PMN K915543 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	UltraPake	2008-02-28
PMN K915543 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	UltraPake	2008-02-28
PMN K900393 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco 3 C3	2008-02-28
PMN K900393 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco 3 C3	2008-02-28
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Edge Shoulder	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Edge Shoulder	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Colorlogic	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Colorlogic	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Cermaco II	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Cermaco II	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco I	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco I	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco 3	2008-02-20
PMN K803310 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco 3	2008-02-20
PMN K992956 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Lucitone FRS	2008-02-19
PMN K992956 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Acetal Resin	2008-02-19
PMN K984427 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Excelsior Porcelain,	2008-02-19
PMN K984427 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Excelsior Porcelain,	2008-02-19
PMN K984427 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco 3 Enamel,	2008-02-19
PMN K984427 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco 3 Enamel,	2008-02-19
PMN K964040 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Luci-Sof	2008-02-19
PMN K926406 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Triad Dualine Dual Cure Reline Mtl	2008-02-19
PMN K923979 | EBH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Triad TruTray	2008-02-19
PMN K882482 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Triad Gel	2008-02-19
PMN K882482 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Eclipse Gel	2008-02-19
PMN K834409 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	VLC	2008-02-19
PMN K834409 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Triad,	2008-02-19
PMN K831647 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Triad	2008-02-19
PMN K831647 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Eclipse	2008-02-19
PMN K061580 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Eclipse Wax Remover,	2008-02-19
PMN K061580 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Clearly Superior,	2008-02-19
PMN K061264 | EBG DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Radica	2008-02-19
PMN K051707 | KLE DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Eclipse Bonding Agent	2008-02-19
PMN K051707 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Eclipse Bonding Agent	2008-02-19
PMN K041335 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco Press	2008-02-19
PMN K041335 | EIH DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Ceramco Press	2008-02-19
PMN K032892 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Eclipse Heat & Seat Resilient Resin	2008-02-19
PMN K011560 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Eclipse	2008-02-19
PMN K933468 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	PermaSoft,	2008-02-18
PMN K933468 | EBI DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	EverSoft	2008-02-18
PMN K980332 | KIF DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	ProRoot MTA	2008-01-28
PMN K011009 | KIF DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	ProRoot MTA, Tooth Colored Formula	2008-01-28
EJT DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Option	2003-10-20
EJS DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	NTA Denticon	2003-07-15
EGG DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Precision Attachment	2003-07-15
EGG DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Attachments	2003-07-15
DZN DENTSPLY PROSTHETICS [DENTSPLY SIRONA INC]	Luxation Instruments	2002-03-18

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092262982	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	53 2360 0001 GENIOS A SHADES, GENIOS P SHADES , EXECUTIVE SHADES, TRUEXPRESSION P SHADES HS	1 PCS
2020091792028	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	53 2360 0001 GENIOS A SHADES, GENIOS P SHADES , EXECUTIVE SHADES, TRUEXPRESSION P SHADES HS	1 PCS
201906113856	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	VACUUM PUMP H.S CODE 8414.10	3 CRT
201906105756	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	VACUUM PUMP H.S CODE 8414.10	3 CRT
201903198479	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	VACUUM PUMP H.S CODE 8414.10	5 CRT
2019031611579	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	VACUUM PUMP H.S CODE 8414.10	5 CRT
201812318236	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	VACUUM PUMP H.S CODE 8414.10	5 CRT
20180901157	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	VACUUM PUMP H.S CODE 8414.10	5 CRT