GC FujiCEM™ 004647

GUDID D0470046471

GC FujiCEM™  2 Dispenser

Gc America Inc.

Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual Dental material cartridge-plunging applicator, two-component, manual

• Primary Device ID: D0470046471
• NIH Device Record Key: 0434b2dc-35a2-41c0-9807-3e84a2332e64
• Commercial Distribution Discontinuation: 2017-11-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GC FujiCEM™
• Version Model Number: 004647
• Catalog Number: 004647
• 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
• 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
HIBCC	D0470046471 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-08
• Device Publish Date: 2016-08-01

On-Brand Devices [GC FujiCEM™]

• D0470046471: GC FujiCEM™ 2 Dispenser
• D0470015732: GC FujiCEM™ GC Paste Pak Dispenser