G-Premio™ Bond 009276

GUDID 04548161327575

G-Premio™ Bond Unit Dose, 50 (0.1mL), unit doses

Gc America Inc.

Dentine bonding agent/set

• Primary Device ID: 04548161327575
• NIH Device Record Key: 04db1132-6da2-41c6-8e4d-c7bb14405542
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-Premio™ Bond
• Version Model Number: 009276
• Catalog Number: 009276
• 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
• 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 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548161327575 [Unit of Use]
GS1	14548161327572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143140

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-Premio™ Bond]

• 04548161327575: G-Premio™ Bond Unit Dose, 50 (0.1mL), unit doses
• 14548161321952: G-Premio™ BOND 5mL Refill
• 14548161321945: G-Premio™ BOND 5mL Kit: 1 bottle 5mL, 50 disposable applicators, 20 disposable trays
• 44548161297517: G-Premio™ BOND DCA 3mL Refill, 1 btl. 3mL
• D0470126961: G-Premio™ BOND 5mL Refill
• D0470126911: G-Premio™ BOND 5mL Kit: 1 bottle 5mL, 50 disposable applicators, 20 disposable trays
• D0470095524: G-Premio™ BOND DCA 3mL Refill, 1 btl. 3mL