BIOCRYL ICE 1# KIT

GUDID D7750470010

GREAT LAKES ORTHODONTICS, LTD.

Dental prosthesis restorative material, unfilled resin
Primary Device IDD7750470010
NIH Device Record Keyf4fd5a68-b6e3-450b-8394-47d5320ef9c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOCRYL ICE 1# KIT
Version Model Number047-001
Company DUNS041854332
Company NameGREAT LAKES ORTHODONTICS, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
HIBCCD7750470010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-11

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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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