Dentalez Inc

FDA Filings

This page includes the latest FDA filings for Dentalez Inc. 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

Registration Number1049061
FEI Number1049061
NameDENTALEZ OF ALABAMA
Owner & OperatorDENTALEZ, INC.
Contact Address2 WEST LIBERTY BLVD. SUITE 160
Malvern PA 19355 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 U.S. HIGHWAY 31 SOUTH
BAY MINETTE, AL 36507 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-24
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-24
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-24
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-17
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-17
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-17
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-17
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2023-07-14
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-05
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-07-01
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-29
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-28
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-28
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-22
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
DENTALEZ, INC.
 StarDental Instrument Solutions 2022-06-21
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.
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece2020-01-06
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
NuTorque Lite Electric Attachments - 263981, 263982, 263983, 263984, 2639852019-11-01
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Solmetix NXT Hg5 - Amalgam Separator2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Remote Panel - On Wall Controller2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Otter - Liquid Storage Tank2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Osprey - Air Compressor2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Osprey - Air Compressor Sound Cover2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC OWL Touch - On Wall Controller2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC InfiniTank - Liquid Storage Tank2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Bulldog - Dry Vacuum System2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Bison - Dry Vacuum System2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Barracuda - Wet Ring Vacuum System2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC Badger LF - Dry Vacuum System2019-10-29
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
RAMVAC 50 Gallon Cylindrical - Liquid Storage Tank2019-10-29
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Lubricant, Electric HP2019-08-08
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Identafi Sheaths2019-03-26
DentalEZ, Inc.
Concentrix MX-AC High-Speed Handpiece2018-03-28
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
Titan 3 Low Speed Angle Attachments2017-01-19
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.
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece2016-04-08
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.
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES2012-01-23
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.
STARCARE HANDPIECE MAINTENANCE UNIT2009-12-28
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 OF ALABAMA [DENTALEZ, INC.]
DentalEZ Simplicity Duo Cart - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ Simplicity Doctor's Cart - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ Simplicity - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ NextGen Duo Cart - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ NextGen Assistant's Cart - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ Galaxy Traditional - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ Galaxy Euro - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ CORE - Unit2008-01-21
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ NuSimplicity - Chair2008-01-18
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ CORE - Chair2008-01-18
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.
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 2644222007-06-15
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 OF ALABAMA [DENTALEZ, INC.]
DentalEZ Simplicity - Light1992-09-30
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ Everlight - Light1992-09-30
DENTALEZ OF ALABAMA [DENTALEZ, INC.]
DentalEZ CORE - Light1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Identafi Disposable Mirror1992-09-30
DENTALEZ, INC., STARDENTAL DIVISION [DENTALEZ, INC.]
Classique Diamond Burs1992-09-30

Related Finance Registrations
NCAGE Code1LST7DENTALEZ, INC.!DBA STAR DENTAL
NCAGE Code2N768DENTALEZ, INC.!DBA DENTALEZ INTEGRATED SOLUTIONS
CAGE Code1LST7DENTALEZ, INC. STAR DENTAL
CAGE Code2N768DENTALEZ, INC. DENTALEZ INTEGRATED SOLUTIONS
S.A.M. Registration2N768 [59010363]DENTALEZ, INC. DENTALEZ INTEGRATED SOLUTIONS
S.A.M. Registration1LST7 [135956183]DENTALEZ, INC. STAR DENTAL
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
201909231007Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDENTIST CHAIR BRACKET 257 . . . .2 PKG
201908087037Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDENTIST CHAIR BRACKET 275 . . . .5 PKG
201905087381Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDENTIST CHAIR BRACKET 259 DENTIST CHAIR BRACKET 258 DENTIST CHAIR BRACKET 261 . .9 PKG
201904106314Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDENTIST CHAIR BRACKET 275 . . . .5 PKG
201901119912Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDENTIST CHAIR BRACKET 275 . . . .2 PKG
2018122912078Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDENTIST CHAIR BRACKET 275 . . . .2 PKG
2018102645622London,United Kingdom -> Charleston, South CarolinaPOWER TRANSFORMERS10 BOX
201810098452Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDENTIST CHAIR BRACKET . . . .2 PKG
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