G-aenial™ Bond 011942

GUDID 14548161296489

G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposable dispensing dish)

Gc America Inc.

Dentine bonding agent/set

• Primary Device ID: 14548161296489
• NIH Device Record Key: db74d4c8-386a-4052-a500-aafab16b73ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-aenial™ Bond
• Version Model Number: 011942
• Catalog Number: 011942
• 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
• 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

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	14548161296489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082768

FDA Product Code

• KLE: AGENT, TOOTH BONDING, 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: 2022-08-15
• Device Publish Date: 2022-08-05

On-Brand Devices [G-aenial™ Bond]

• 14548161296526: G-aenial™ Bond (1 x 5 mL bottle) Refill
• 14548161296489: G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab
• 14548161282826: G-aenial™ Bond (1 x 5 mL bottle)
• 14548161282628: G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab
• D0470119471: G-aenial™ Bond (1 x 5 mL bottle) Refill
• D0470119421: G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab
• D0470042201: G-aenial™ Bond (1 x 5 mL bottle)
• D0470042171: G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab