Dentalez Inc Stardental Division

FDA Filings

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

FDA Registration(s)
Registration Number2520265
FEI Number2520265
NameDENTALEZ, INC., STARDENTAL DIVISION
Owner & OperatorDENTALEZ, INC.
Contact Address2 WEST LIBERTY BLVD. SUITE 160
Malvern PA 19355 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1816 Colonial Village Ln
LANCASTER, PA 17601 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Aeras 500 Swlvel, Fiber Optic2020-01-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Aeras 500 Swivel, non-Fiber Optic2020-01-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Aeras 500 Elite Handpiece, Lubricated, Fiber Optic2020-01-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Aeras 500 Elite Handpiece, Lubricated non-Fiber Optic2020-01-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Aeras 500 Elite Handpiece, LubeFree, non-Fiber Optic2020-01-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Aeras 500 Elite Handpiece, LubeFree, Fiber Optic2020-01-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
NuTorque Lite Electric Attachments - 263981, 263982, 263983, 263984, 2639852019-11-01
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Lubricant, Electric HP2019-08-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Identafi Sheaths2019-03-26
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
ETorque Handpieces - 265471, 265472, 265473, 265474, 2654752017-11-07
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Star ETorque Electric Motor System - 265461, 265464, 2654632017-11-07
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
LED Swivel2016-04-21
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
LED Plug N Play Swivel Assembly2016-04-21
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
HiFlo Fiber Optic Swivel2016-04-21
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
5-Hole Fiber Optic Swivel2016-04-21
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
4-line Non-Fiber Optic Swivel2016-04-21
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
2-line Non-Fiber Optic Swivel2016-04-21
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
StarBright Single Lamp Control System2015-10-27
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
StarBright Dual Lamp Control System2015-10-27
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
iStar Cordless Prophy Handpiece2015-02-02
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan E-lectric Attachments2011-05-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
NuTorque Lite Electric Attachments - 2639862011-05-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Identafi2011-03-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Identafi Patient Eyewear2011-03-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan E-lectric Motor System2009-02-24
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
NuTorque Programmable Electric System - 265199, 2652002009-02-24
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan-T Motors2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan-T Lubricated Angles2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan-T Lubefree Angles2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan-T Attachments2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan-E 20K Motor2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan EX Motor 20K2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan EX Attachments2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan EX Angles2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan 3 Motors2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan 3 Lubricated Angles2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan 3 Lubefree Angles2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan 3 Attachments2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Solara Series High-Speed Handpieces2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Simplicity Series High Speed Handpieces2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Prophy Star 3 Hygiene Handpiece2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Dentalube II Advanced Handpiece Lubricant2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Concentrix Series High-Speed Handpieces2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
6 Pin Flex Swivel2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
430 Series High-Speed Handpieces2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Titan Blis-sonic Scalers2007-10-10
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Hand Instruments Explorers - Endodontic1999-11-15
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Hand Instrument - Curettes1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Hand Instruments - Scalers1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Hand Instruments - Pluggers1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Hand Instrument - Spreaders1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Hand Instruments - Excavators1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Visi-Frame1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Identafi Disposable Mirror1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Classique Diamond Burs1992-09-30

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