GC FujiCEM™ 2 431577

GUDID 00386040009181

GC Fuji Intraoral Tip SL, 10 pcs

Gc America Inc.

Glass ionomer dental cement
Primary Device ID00386040009181
NIH Device Record Key3651583f-21af-4709-83bf-3247a288ebf0
Commercial Distribution StatusIn Commercial Distribution
Brand NameGC FujiCEM™ 2
Version Model Number431577
Catalog Number431577
Company DUNS005473608
Company NameGc America Inc.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100386040009181 [Unit of Use]
GS110386040009188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACEMENT, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-21
Device Publish Date2022-07-13

On-Brand Devices [GC FujiCEM™ 2]

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

Trademark Results [GC FujiCEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GC FUJICEM
GC FUJICEM
76186124 2506680 Live/Registered
TRADEMARK HOLDINGS OF ILLINOIS LLC
2000-12-26

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