COE-COMFORT™ 341001

GUDID 20386040000335

COE-COMFORT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid and accessories)

Gc America Inc.

Denture reliner, elastic, short-term Denture reliner, elastic, short-term Denture reliner, elastic, short-term Denture reliner, elastic, short-term Denture reliner, elastic, short-term Denture reliner, elastic, short-term Denture reliner, elastic, short-term Denture reliner, elastic, short-term Denture reliner, elastic, short-term

• Primary Device ID: 20386040000335
• NIH Device Record Key: 290bc4da-3f96-463a-b7d3-a69f39ed76cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COE-COMFORT™
• Version Model Number: 341001
• Catalog Number: 341001
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040000338 [Primary]
GS1	20386040000335 [Package]; Contains: 10386040000338; Package: Carton [6 Units]; In Commercial Distribution

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)