GC Fuji IX GP® 425050

GUDID 00386040008948

GC Fuji IX GP® EXTRA Capsule (48) Assorted Starter (10 each of A2, A3,A3.5, 9 each of B1 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)

Gc America Inc.

Glass ionomer dental cement

• Primary Device ID: 00386040008948
• NIH Device Record Key: 7cb90fb6-df26-4e87-993b-d89e7dd784ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Fuji IX GP®
• Version Model Number: 425050
• Catalog Number: 425050
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 48
• 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

Operating and Storage Conditions

• 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
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386040008948 [Unit of Use]
GS1	10386040008945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070319

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 IX GP®]

• 10386040009881: GC Fuji IX GP® Starter Package, A2 (1 x 15g powder, 1 x 6.4mL liquid, 1 x GC CAVITY CONDITIONER
• 00386040009099: GC Fuji IX GP® Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, Capsu
• 00386040009082: GC Fuji IX GP® Capsule (48)- B3
• 00386040009075: GC Fuji IX GP® Capsule (48)- B2
• 00386040009068: GC Fuji IX GP® Capsule (48)- A3.5
• 00386040009051: GC Fuji IX GP® Capsule (48)- A3
• 00386040009044: GC Fuji IX GP® Capsule (48)- A2
• 00386040009037: GC Fuji IX GP® Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3)
• 00386040009020: GC Fuji IX GP® FAST Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3,
• 00386040009013: GC Fuji IX GP® FAST Capsule (48)-A1
• 00386040009006: GC Fuji IX GP® FAST Capsule (48)- B3
• 00386040008993: GC Fuji IX GP® FAST Capsule (48)- B2
• 00386040008986: GC Fuji IX GP® FAST Capsule (48)- A3.5
• 00386040008979: GC Fuji IX GP® FAST Capsule (48)- A3
• 00386040008962: GC Fuji IX GP® FAST Capsule (48)- A2
• 00386040008955: GC Fuji IX GP® FAST Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3)
• 00386040008948: GC Fuji IX GP® EXTRA Capsule (48) Assorted Starter (10 each of A2, A3,A3.5, 9 each of B1 & B3,
• 00386040008931: GC Fuji IX GP® EXTRA Capsule (48) - C4
• 00386040008924: GC Fuji IX GP® EXTRA Capsule (48) - B3
• 00386040008917: GC Fuji IX GP® EXTRA Capsule (48) - B2
• 00386040008900: GC Fuji IX GP® EXTRA Capsule (48) - B1
• 00386040008894: GC Fuji IX GP® EXTRA Capsule (48)- A3.5
• 00386040008887: GC Fuji IX GP® EXTRA Capsule (48) - A3
• 00386040008870: GC Fuji IX GP® EXTRA Capsule (48) - A2
• 00386040008863: GC Fuji IX GP® EXTRA Capsule (48)- A1
• 00386040008856: GC Fuji IX GP® EXTRA Assorted Pkg Capsule (48) (10 each of A2 A3,A3.5, 9 each of B1 & B3)
• 24548161329634: GC Fuji IX GP® Intro Package, 1-1 Pack,1 btl. Powder, Shade A2 (15g) 1 btl liquid (6.4ml), mixi
• 24548161282328: GC Fuji IX GP® A2, 15 g powder
• 24548161282298: GC Fuji IX GP® 6.4 mL liquid btl.