COE TRAY PLASTIC™ 240192

GUDID 10386040006453

COE TRAY PLASTIC™ Fast Set Liquid Can 1 Pint (473mL)

Gc America Inc.

Dental impression spacer Dental impression spacer Dental impression spacer Dental impression spacer Dental impression spacer Dental impression spacer Dental impression spacer Dental impression spacer Dental impression spacer

• Primary Device ID: 10386040006453
• NIH Device Record Key: 5a562802-3f4d-4e01-bb8b-30db63575622
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COE TRAY PLASTIC™
• Version Model Number: 240192
• Catalog Number: 240192
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• 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: false
• 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: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Dimensions

• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter
• Total Volume: 473 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040006453 [Primary]

FDA Product Code

• EBH: MATERIAL, IMPRESSION TRAY, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [COE TRAY PLASTIC™]

• D6582401941: COE TRAY PLASTIC™ Fast Set Liquid 1 gallon (4 1-qt. cans)
• 10386040006460: COE TRAY PLASTIC™ Fast Set Liquid Can 1 Quart (946mL)
• 10386040006453: COE TRAY PLASTIC™ Fast Set Liquid Can 1 Pint (473mL)
• 10386040006446: COE TRAY PLASTIC™ Fast Set Liquid bottle 6 oz. (117mL)
• 10386040006439: COE TRAY PLASTIC™ Fast Set-White Economy Package, powder 3 lbs. (1.4kg), liquid 1 pt. (473mL),
• 10386040006422: COE TRAY PLASTIC™ Professional Package, Fast Set White powder 1 lb. (454g), Liquid 6 oz. (177m
• 10386040006408: COE TRAY PLASTIC™ Regular Set Liquid can 1 quart (946 mL)
• 10386040006392: COE TRAY PLASTIC™ Liquid can 1 pint (473mL)
• 10386040006385: COE TRAY PLASTIC™ Liquid bottle 6 oz. (117mL)
• 10386040006378: COE TRAY PLASTIC™ Powder Drum 25 lb. White
• 10386040006361: COE TRAY PLASTIC™ Powder Jar 3 lb. (1.4 kg)
• 10386040006354: COE TRAY PLASTIC™ Regular set-White powder 3 lbs. (1.4kg), Liquid 1 pt. (473mL), Coe-Sep 2 2-
• 10386040006347: COE TRAY PLASTIC™ Powder Jar 1 lb. (454g)
• 10386040006330: COE TRAY PLASTIC™ Professional Package, Regular Set White, powder 1 lb (454g), liquid 6 oz.