COE-SOFT™ 344033

GUDID 10386040007030

COE-SOFT™ Liquid Refill 5.5oz

Gc America Inc.

Denture reliner, soft, professional

• Primary Device ID: 10386040007030
• NIH Device Record Key: 49ba781e-7946-4415-b7f0-973156177f3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COE-SOFT™
• Version Model Number: 344033
• Catalog Number: 344033
• 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: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce
• Total Volume: 5.5 Fluid Ounce

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	10386040007030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070697

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-SOFT™]

• 10386040007047: COE-SOFT™ 1qt liquid
• 10386040007030: COE-SOFT™ Liquid Refill 5.5oz
• 10386040007023: COE-SOFT™ Powder 5.5oz
• 20386040007013: COE-SOFT™ 5.5oz Prof. Pkg (1 x 5.5oz powder, 1 x 5.5oz liquid, 18mL lubricant and accessories)
• 10386040006996: COE-SOFT™ Economy Package (1 x 5lb powder)
• 10386040003735: COE-SOFT™ 18mL lubricant
• 00386040003714: COE-SOFT™ Economy Package (1 x 5lb powder, 2 x qt liquid)
• 10386040003728: COE-SOFT Liquid 6oz
• 10386040003704: COE-SOFT Powder 6oz
• 10386040000345: COE-SOFT Professional Package