G-aenial™ Bond 004217

GUDID D0470042171

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: D0470042171
• NIH Device Record Key: 31273125-e4d5-42ba-85a4-090252095c55
• Commercial Distribution Discontinuation: 2017-09-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: G-aenial™ Bond
• Version Model Number: 004217
• Catalog Number: 004217
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0470042171 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-16
• Device Publish Date: 2016-08-01

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• D0470042171: G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab