2oz AMBER DYE CONCENTRATE 045-036

GUDID D7750450360

2oz AMBER DYE CONCENTRATE

GREAT LAKES ORTHODONTICS, LTD.

Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin Dental prosthesis restorative material, unfilled resin
Primary Device IDD7750450360
NIH Device Record Keyb542c3f0-dc7a-4139-8a06-d1a4b166fd36
Commercial Distribution StatusIn Commercial Distribution
Brand Name2oz AMBER DYE CONCENTRATE
Version Model Number045-036
Catalog Number045-036
Company DUNS041854332
Company NameGREAT LAKES ORTHODONTICS, LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com
Phone8008287626
Emailinfo@greatlakesortho.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7750450360 [Primary]

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

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D7753004010 - LG DRYFIELD KIT WHITE *I 2018-10-05 LG DRYFIELD KIT WHITE *I
D7753004060 - RETRACTOR - LARGE WHITE *I 2018-10-05 RETRACTOR - LARGE WHITE *I
D7753004140 - RETRACTOR - SMALL RED *I 2018-10-05 RETRACTOR - SMALL RED *I
D7753006120 - LARGE LIP RETRACTOR *O 2018-10-05 LARGE LIP RETRACTOR *O
D7753006140 - SMALL LIP RETRACTOR *O 2018-10-05 SMALL LIP RETRACTOR *O
D7753006260 - GL INTRAORAL MOUTH PROPS 2018-10-05 GL INTRAORAL MOUTH PROPS
D7753006270 - GL INTRAORAL MOUTH PROPS 2018-10-05 GL INTRAORAL MOUTH PROPS
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