COE TRAY PLASTIC™ 240013

GUDID D6582400131

COE TRAY PLASTIC™ Regular set-White powder 3 lbs. (1.4kg), Liquid 1 pt. (473mL), Coe-Sep 2 2-oz. (118mL)

Gc America Inc.

Dental impression spacer

• Primary Device ID: D6582400131
• NIH Device Record Key: 7bdb92e7-dbd8-4fe6-9562-21355ff7566a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COE TRAY PLASTIC™
• Version Model Number: 240013
• Catalog Number: 240013
• 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
• 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

Operating and Storage Conditions

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6582400131 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-01-21
• Device Publish Date: 2017-02-10

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.
• D6582401931: COE TRAY PLASTIC™ Fast Set Liquid Can 1 Quart (946mL)
• D6582401921: COE TRAY PLASTIC™ Fast Set Liquid Can 1 Pint (473mL)
• D6582401911: COE TRAY PLASTIC™ Fast Set Liquid bottle 6 oz. (117mL)
• D6582401131: COE TRAY PLASTIC™ Fast Set-White Economy Package, powder 3 lbs. (1.4kg), liquid 1 pt. (473mL),
• D6582401111: COE TRAY PLASTIC™ Professional Package, Fast Set White powder 1 lb. (454g), Liquid 6 oz. (177m
• D6582400931: COE TRAY PLASTIC™ Regular Set Liquid can 1 quart (946 mL)
• D6582400921: COE TRAY PLASTIC™ Liquid can 1 pint (473mL)
• D6582400911: COE TRAY PLASTIC™ Liquid bottle 6 oz. (117mL)
• D6582400161: COE TRAY PLASTIC™ Powder Drum 25 lb. White
• D6582400141: COE TRAY PLASTIC™ Powder Jar 3 lb. (1.4 kg)
• D6582400131: COE TRAY PLASTIC™ Regular set-White powder 3 lbs. (1.4kg), Liquid 1 pt. (473mL), Coe-Sep 2 2-
• D6582400121: COE TRAY PLASTIC™ Powder Jar 1 lb. (454g)
• D6582400111: COE TRAY PLASTIC™ Professional Package, Regular Set White, powder 1 lb (454g), liquid 6 oz.