Great Lakes Dental Technologies L T D

FDA Filings

This page includes the latest FDA filings for Great Lakes Dental Technologies L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Great Lakes Dental Technologies L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1316408
FEI Number1316408
NameGreat Lakes Dental Technologies, Ltd.
Owner & OperatorGreat Lakes Dental Technologies, Ltd.
Contact Address200 COOPER AVE. --
Tonawanda NY 14150 US
Official Correspondent
  • Joseph Mazurkiewicz
  • 1-800-8287626-239
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address200 COOPER AVENUE
TONAWANDA, NY 14150 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Great Lakes Dental Technologies, Ltd.
Titanium Molybdenum Wire 2022-03-31
Great Lakes Dental Technologies, Ltd.
Titanium Molybdenum Wire 2022-03-31
Great Lakes Dental Technologies, Ltd.
Titanium Molybdenum Wire 2022-03-31
Great Lakes Dental Technologies, Ltd.
The George Gauge Kit 2021-02-16
Great Lakes Dental Technologies, Ltd.
Medley Gold2019-08-07
Great Lakes Dental Technologies, Ltd.
Smart Moves Complete2018-06-05
Great Lakes Dental Technologies, Ltd.
Smart Moves Complete2018-06-05
Great Lakes Dental Technologies, Ltd.
RHEA Occlusal Appliance2016-05-16
Great Lakes Dental Technologies, Ltd.
eXceed2016-03-29
Great Lakes Dental Technologies, Ltd.
eXceed2016-03-29
Great Lakes Dental Technologies, Ltd.
eXceed2016-03-29
Great Lakes Dental Technologies, Ltd.
Dentasoak2015-06-03
Great Lakes Dental Technologies, Ltd.
Biocryl ICE2014-07-24
Great Lakes Dental Technologies, Ltd.
Herbst Sleep Appliance2011-02-18
Great Lakes Dental Technologies, Ltd.
Klearway Appliance2011-02-18
Great Lakes Dental Technologies, Ltd.
Elastomeric Appliance2011-02-18
Great Lakes Dental Technologies, Ltd.
NAPA Appliance2011-02-18
Great Lakes Dental Technologies, Ltd.
Petit Mask2011-02-18
Great Lakes Dental Technologies, Ltd.
Keles Mask2011-02-18
Great Lakes Dental Technologies, Ltd.
Great Lakes Bite Registration wax2011-02-18
Great Lakes Dental Technologies, Ltd.
EZ Key2010-04-21
Great Lakes Dental Technologies, Ltd.
Aculight2010-04-21
Great Lakes Dental Technologies, Ltd.
Great Lakes Ortho Doppler2010-02-03
Great Lakes Dental Technologies, Ltd.
Nola Head gear2009-04-16
Great Lakes Dental Technologies, Ltd.
Great Lakes Face Cribs2009-04-16
Great Lakes Dental Technologies, Ltd.
Biocryl X2009-04-15
Great Lakes Dental Technologies, Ltd.
Splint Biocryl Resin2009-03-03
Great Lakes Dental Technologies, Ltd.
Biocryl Resin2009-03-03
Great Lakes Dental Technologies, Ltd.
Nola Dryfield System and accesories2008-03-06
Great Lakes Dental Technologies, Ltd.
Dentasoak2007-11-14
Great Lakes Dental Technologies, Ltd.
Variflex2007-11-14
Great Lakes Dental Technologies, Ltd.
LIP RETRACTOR2006-08-31
Great Lakes Dental Technologies, Ltd.
PERIO TRAY2006-05-11
Great Lakes Dental Technologies, Ltd.
PERIO PROTECT TRAY2006-05-11
Great Lakes Dental Technologies, Ltd.
Great Lakes Ball clasps1994-07-21
Great Lakes Dental Technologies, Ltd.
Great Lakes Arrow clasps1994-07-21
Great Lakes Dental Technologies, Ltd.
Great Lakes Adams clasps1994-07-21
Great Lakes Dental Technologies, Ltd.
Great Lakes Stainless Steel wire1994-03-15
Great Lakes Dental Technologies, Ltd.
Duralloy Wire1994-03-15
Great Lakes Dental Technologies, Ltd.
Lucia Jig1992-06-29
Great Lakes Dental Technologies, Ltd.
George Gauge1992-06-29
Great Lakes Dental Technologies, Ltd.
Smart Moves1992-06-29
Great Lakes Dental Technologies, Ltd.
RES Screw1992-06-29
Great Lakes Dental Technologies, Ltd.
MOUTHGUARD MATERIAL1992-06-29
Great Lakes Dental Technologies, Ltd.
Invisacryl1992-06-29
Great Lakes Dental Technologies, Ltd.
Invisacryl Ultra1992-06-29
Great Lakes Dental Technologies, Ltd.
GREAT LAKES BIOCRYL1992-06-29
Great Lakes Dental Technologies, Ltd.
Biocryl Form-X1992-06-29

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