GC FujiCEM™ 2

Basic Information

• Brand Name: GC FujiCEM™ 2
• Primary DI: D6584315771
• Version / Model: 431577
• Catalog Number: 431577
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4f3a0e1f-3298-407e-9baf-fcd5a3438a60

Device Description

GC FujiCEM™  2 (10) Mixing Intraoral Tip SL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	CEMENT, DENTAL	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16704	Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6584315771	HIBCC
Unit of Use	D6584315770	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K001730	000