1LB NEON GLOW POWDER 045-019

GUDID D7750450190

1LB NEON GLOW POWDER

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 IDD7750450190
NIH Device Record Key9a5fa43f-c62a-4e57-aec0-6cc9d5ad6081
Commercial Distribution StatusIn Commercial Distribution
Brand Name1LB NEON GLOW POWDER
Version Model Number045-019
Catalog Number045-019
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

Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com
Phone800-828-7626
Emailinfo@greatlakesortho.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7750450190 [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 Date2016-09-12

Devices Manufactured by GREAT LAKES ORTHODONTICS, LTD.

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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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