G-Bond ™ 002302

GUDID D0470023021

G-Bond ™ Starter Kit, Unit Dose (50 x 0.1 mL unit doses & 50 x disposable applicators)

Gc America Inc.

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• Primary Device ID: D0470023021
• NIH Device Record Key: 2668a2e9-bc35-4795-8bf8-be76a279835d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-Bond ™
• Version Model Number: 002302
• Catalog Number: 002302
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 50
• 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: true
• 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: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0470023020 [Unit of Use]
HIBCC	D0470023021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041471

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

On-Brand Devices [G-Bond ™]

• 14548161074728: G-Bond ™ Starter Kit, Bottle (1 x 5 mL bottle, 50 x disposable applicators & 1 x dispenser tra
• 04548161075667: G-Bond ™ Starter Kit, Unit Dose (50 x 0.1 mL unit doses & 50 x disposable applicators)
• D0470023021: G-Bond ™ Starter Kit, Unit Dose (50 x 0.1 mL unit doses & 50 x disposable applicators)
• D0470022771: G-Bond ™ Starter Kit, Bottle (1 x 5 mL bottle, 50 x disposable applicators & 1 x dispenser tra