COE-COMFORT™ 341092

GUDID 10386040006873

COE-COMFORT™ 1qt liquid

Gc America Inc.

Denture reliner, soft, professional

• Primary Device ID: 10386040006873
• NIH Device Record Key: 74f6a03e-5fa1-4635-8447-32d972f7602e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COE-COMFORT™
• Version Model Number: 341092
• Catalog Number: 341092
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 1 Quart
• Total Volume: 1 Quart
• Total Volume: 1 Quart
• Total Volume: 1 Quart
• Total Volume: 1 Quart
• Total Volume: 1 Quart
• Total Volume: 1 Quart
• Total Volume: 1 Quart
• Total Volume: 1 Quart

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	10386040006873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070698

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: 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-COMFORT™]

• 10386040006873: COE-COMFORT™ 1qt liquid
• 10386040006859: COE-COMFORT™ 5lb Jar powder
• 10386040003667: COE-COMFORT™ 6oz liquid
• 10386040000840: COE-COMFORT™ 6oz powder
• 20386040000335: COE-COMFORT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid and accessories)