GC Fuji PLUS® 431091

GUDID 20386040009154

GC Fuji PLUS® 7mL liquid

Gc America Inc.

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: 20386040009154
• NIH Device Record Key: bc26d456-41f3-4c54-bb8b-6a524ad4e0b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Fuji PLUS®
• Version Model Number: 431091
• Catalog Number: 431091
• 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	10386040009157 [Primary]
GS1	20386040009154 [Package]; Contains: 10386040009157; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946100

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 PLUS®]

• 10386040009164: GC Fuji PLUS® No Etch Package (1 x 15g powder, 1 x 7mL liquid & accessories)
• 20386040009154: GC Fuji PLUS® 7mL liquid
• 20386040009147: GC Fuji PLUS® 15g powder
• 20386040009130: GC Fuji PLUS® 1:1 Kit (1 x 15g powder, 1 x 7mL liquid, 1 x GC Fuji PLUS CONDITIONER & accessori
• 00386040008849: GC Fuji PLUS® Capsule No-Etch Starter Package 48 capsules (0.36g powder; 0.16mL liquid per caps
• 00386040008832: GC Fuji PLUS® Capsule Package Quantity of 48 capsules (0.36g powder; 0.16mL liquid per capsule)
• 24548161283080: GC Fuji PLUS® Conditioner btl. (6.5 mL)