GC FujiCEM™ 2 431577

GUDID 00386040009181

GC Fuji Intraoral Tip SL, 10 pcs

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: 00386040009181
• NIH Device Record Key: 3651583f-21af-4709-83bf-3247a288ebf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC FujiCEM™ 2
• Version Model Number: 431577
• Catalog Number: 431577
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 10
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386040009181 [Unit of Use]
GS1	10386040009188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001730

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 FujiCEM™ 2]

• 10386040009966: GC FujiCEM™ 2 (w/o mixing tips; Automix Compatible) (Two (7.2mL; 13.3g) cartridges and a #22 M
• 10386040009959: GC FujiCEM™ 2 Starter Kit (One (7.2mL; 13.3g) cartridge, 20 mixing tips and 1 GC FujiCEM 2 Dis
• 10386040009942: GC FujiCEM™ 2 Automix Package (Two (7.2mL; 13.3g) cartridges and 42 mixing tips)
• 00386040009198: GC FUJICEM 2 Mixing Tip SL, 20 pcs
• 00386040009181: GC Fuji Intraoral Tip SL, 10 pcs