GC Fuji II LC® 425002

GUDID 00386040008726

GC Fuji II LC® A2, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)

Gc America Inc.

Glass ionomer dental cement

• Primary Device ID: 00386040008726
• NIH Device Record Key: eddf8c28-8516-47f2-bfe0-63ec7af7a343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Fuji II LC®
• Version Model Number: 425002
• Catalog Number: 425002
• 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 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	00386040008726 [Unit of Use]
GS1	10386040008723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993973

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 II LC®]

• 00386040008825: GC Fuji II LC® Dark Shades, Quantity of 24 capsules (5 each of A3.5, A4, B3 and B4 shades; 4 ea
• 00386040008818: GC Fuji II LC® Light Shades, Quantity of 24 capsules (5 each of A1, A2, A3 and B2 shades; 4 eac
• 00386040008801: GC Fuji II LC® C4, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008795: GC Fuji II LC® C2, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008788: GC Fuji II LC® B4, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008771: GC Fuji II LC® B3, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008764: GC Fuji II LC® B2, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008757: GC Fuji II LC® A4, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008740: GC Fuji II LC® A3.5, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008733: GC Fuji II LC® A3, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008726: GC Fuji II LC® A2, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 00386040008719: GC Fuji II LC® A1, 48 capsules of the same shade (0.33g powder; 0.085mL liquid per capsule)
• 14548161329828: GC Fuji II LC® C4, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories)
• 14548161329804: GC Fuji II LC® B4, 15 g powder, 1 btl liquid (6.8mL), accessories
• 14548161329798: GC Fuji II LC® B3, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
• 14548161329781: GC Fuji II LC® B2, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories)
• 14548161329774: GC Fuji II LC® A4, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
• 14548161329767: GC Fuji II LC® A3.5, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories)
• 24548161329818: GC Fuji II LC® C2, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
• 24548161329757: GC Fuji II LC® A3, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
• 24548161329740: GC Fuji II LC® A2, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories)
• 24548161329733: GC Fuji II LC® A1, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
• 24548161329726: GC Fuji II LC® Core (5.1mL) liquid btl
• 24548161329719: GC Fuji II LC® Core 35 g powder btl.
• 24548161329702: GC Fuji II LC® Core 1-2 Package (1 x 35 g powder, 2 x 5 mL liquid, 1 x scoop, 1 x mixing pad)
• 24548161329429: GC Fuji II LC® 50 FUJI CAP #23 DARK GRAY
• 24548161329412: GC Fuji II LC® 50 CAP #22 YELLOW BRN
• 24548161329405: GC Fuji II LC® 50 CAP #21 PALE YELLOW
• 24548161293638: GC Fuji II LC® B4, 15 g powder btl
• 24548161283288: GC Fuji II LC® A1, 15 g powder btl.
• 24548161283264: GC Fuji II LC® A4, 15 g powder btl.
• 24548161283141: GC Fuji II LC® B3, 15 g powder btl
• 24548161283134: GC Fuji II LC® C2, 15 g powder btl
• 24548161282908: GC Fuji II LC® C4, 15 g powder btl
• 24548161282816: GC Fuji II LC® B2, 15 g powder btl
• 24548161282472: GC Fuji II LC® A3.5, 15 g powder btl
• 24548161282427: GC Fuji II LC® A2, 15 g powder btl
• 24548161282373: GC Fuji II LC® A3, 15 g powder btl
• 24548161282304: GC Fuji II LC® 6.8 mL liquid btl