BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

GC Fuji II®

DI: D0470001131 · Model: 000113 · Gc America Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

50

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Basic Information

Brand Name: GC Fuji II®
Primary DI: D0470001131
Version / Model: 000113
Catalog Number: 000113
Company Name: Gc America Inc.
Labeler DUNS: 005473608
Distribution Status: In Commercial Distribution
Device Count in Pkg: 50
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: bd156174-edd2-4dab-8ab8-9723f4ffd1b5

Device Description

GC Fuji II® FUJI II CAPSULE (50) ASSORTMENT

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
Package	D0470001132	HIBCC	Carton	5	In Commercial Distribution
Primary	D0470001131	HIBCC
Unit of Use	D0470001130	HIBCC

Customer Contacts

Phone: +1(708)597-0900
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K880848	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 39 – 77 Degrees Fahrenheit
Type: Storage Environment Temperature
Temperature Range: 4 – 25 Degrees Celsius