GC Fuji Filling™ 439881

GUDID 10386040009874

GC Fuji Filling™ LC Starter Package (1 x 8g (3.9mL) shade A2 Cartridge, 1 x GC Paste Pak Dispenser, 1 x 3.2mL GC SELF CONDITIONER, 1 x spatula)

Gc America Inc.

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• Primary Device ID: 10386040009874
• NIH Device Record Key: 93f3136d-dd1f-4427-907c-b4cae882c4b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Fuji Filling™
• Version Model Number: 439881
• Catalog Number: 439881
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040009874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051427

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [GC Fuji Filling™]

• 10386040009874: GC Fuji Filling™ LC Starter Package (1 x 8g (3.9mL) shade A2 Cartridge, 1 x GC Paste Pak Dispe
• 14548161394338: GC Fuji Filling™ Blue, 8 g (3.9 mL) cartridge, mixing pad
• 14548161394314: GC Fuji Filling™ CV, 8 g (3.9 mL) cartridge, mixing pad
• 14548161394291: GC Fuji Filling™ A3.5, 8 g (3.9 mL) cartridge, mixing pad
• 14548161394284: GC Fuji Filling™ A3, 8 g (3.9 mL) cartridge, mixing pad
• 14548161394277: GC Fuji Filling™ A2, 8 g (3.9 mL) cartridge, mixing pad
• 14548161394260: GC Fuji Filling™ A1, 8 g (3.9 mL) cartridge, mixing pad
• 14548161078436: GC Fuji Filling™ 3g (3.2 mL) liquid