2oz AMBER DYE CONCENTRATE 045-036

GUDID D7750450360

2oz AMBER DYE CONCENTRATE

GREAT LAKES ORTHODONTICS, LTD.

Dental prosthesis restorative material, unfilled resin

• Primary Device ID: D7750450360
• NIH Device Record Key: b542c3f0-dc7a-4139-8a06-d1a4b166fd36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2oz AMBER DYE CONCENTRATE
• Version Model Number: 045-036
• Catalog Number: 045-036
• Company DUNS: 041854332
• Company Name: GREAT LAKES ORTHODONTICS, LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com
• Phone: 8008287626
• Email: info@greatlakesortho.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7750450360 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

Devices Manufactured by GREAT LAKES ORTHODONTICS, LTD.

• D7753004000 - SM DRYFIELD KIT RED *I: 2018-10-05 SM DRYFIELD KIT RED *I
• 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