Dentsply North America L L C

FDA Filings

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

FDA Registration(s)
Registration Number3006186796
FEI Number3006186796
NameDENTSPLY NORTH AMERICA LLC
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 ImporterN
Registration Expiration2020-04-25
Registration Address1800 Cloister Drive
Lancaster, PA 17601 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Elation MB2009-07-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Allure MB2009-03-23
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Mystique MB2008-12-23
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
CP Bracket System2008-06-02
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Saliva Ejector & Adapter Tubes2008-04-08
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Triad Gel2008-02-19
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Eclipse Gel2008-02-19
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Mouth Mirrors2008-01-29
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
ImprESSIX2008-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Retainer Brite2005-12-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Modulmix2005-12-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Hurrimix2005-12-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Hurrimix 22005-12-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Elite Mix2005-12-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
NTA Denticon2003-07-15
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Luxation Instruments2002-03-18
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Universal Tray Adhesive1999-04-05
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MTML Impression Tray Pack1999-04-05
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MTM Clear Aligner Patient Case (contains only impression trays, not aligners)1999-04-05
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
HiTray1999-04-05
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MTM Premium Welcome Kit1997-06-27
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MTM Premium Kit1997-06-27
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Dental Tools1997-06-27
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Weiner Schultz Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Single Wing Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Short Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Roth Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Roncone Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Ricketts Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Resolve Weldable Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Puecat Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Positive Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
OmniArch Weldable Brackets1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
OVATION Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Mcglaughlin-Bennetts Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Mandibular Tubes, Triple, Double and Single1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MACRO Welddable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Lip Bumper Tube Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Light Torque Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Kosaka Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Hilgers Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Hasund Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Greenfield Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Fabricated Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Fabricated Tubes, Weldable1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
EURO Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Dolan Weldable Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Cetlin Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Canada Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Bio-Effient Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Bi-Dimensional Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Balance Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Andrew Buccal Tubes1997-01-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Snap-Fit Bands1997-01-27
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
ShapeFit Bands1997-01-27
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Ideal Bands1997-01-27
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Zircon diamond burr set1995-08-11
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Weldable Omni1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Weldable Micro Arch1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Weldable Brackets1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
U-FLEX1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Twin Edgewise Weldable Brackets1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Single Edgewise Weldable Brackets1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
STOP TUBE1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
SOLID CRIMPABLE STOP1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
SLIDING HOOK1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Resolve?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Ovation?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
OmniArch?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
OmniArch? +1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
OMEGA1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Mini Ovation?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MicroLoc1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Micro Progressive Weldable Brackets1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MYSTIQUE?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MTM? NO TRACE?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MINI PIN & LIGATURE CUTTER1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MICROARCH?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MICROARCH? +1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
MAXILLARY EXPANDER ARM BENDER1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Lingual Attachments1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Lewis Weldable Brackets1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
LIP BUMPER1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
KOBAYASHI1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
IN-OVATION?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
IN-OVATION? mini1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
IN-OVATION? mini Rhodium1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
IN-OVATION? X1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
IN-OVATION? R1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
IN-OVATION? L1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
IDEAL? LIP BUMPER1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
GREENFIELD1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
GREENFIELD LIP BUMPER1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
GENERUS? II1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
GENERUS1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
GAC METAL BRACKET?+1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
GAC Custom Welded Bands and Brackets1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
ERUPTION APPLIANCE1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
ELASTIC HOOK1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
CROWDER STOPS1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
CRIMPABLE STOP1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
CRIMPABLE HOOK1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
CETLIN?1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
CCO? SYSTEM TRANSITION KIT1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
CAPLIN1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Ball Clasp1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
BALANCE? Base Rx1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
BALANCE? BARBOSA1992-08-12
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
NUPRO1977-12-28
DENTSPLY NORTH AMERICA LLC [DENTSPLY SIRONA INC]
Bracket Height Gauge1977-12-15

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