UniFil® 000063

GUDID D0470000631

UniFil® 6 mL self-etching primer liquid

Gc America Inc.

Dentine bonding agent/set
Primary Device IDD0470000631
NIH Device Record Keyf3c89c84-498a-45e3-b1b5-26cea69aea61
Commercial Distribution Discontinuation2019-03-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameUniFil®
Version Model Number000063
Catalog Number000063
Company DUNS005473608
Company NameGc America Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
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 Dimensions

Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0470000631 [Primary]

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-16
Device Publish Date2016-08-01

On-Brand Devices [UniFil®]

D6584210011UniFil® UniFil Bond Starter Kit (1 x 6mL bottle of UniFil Bond Self-Etching Primer, 1 x 6mL bot
D0470000641UniFil® 6 mL bonding agent liquid
D0470000631UniFil® 6 mL self-etching primer liquid

Trademark Results [UniFil]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNIFIL
UNIFIL
77060215 3390786 Live/Registered
MIDWEST FILTRATION LLC
2006-12-08
UNIFIL
UNIFIL
75498543 2516066 Live/Registered
GC CORPORATION
1998-06-09
UNIFIL
UNIFIL
74518127 1934821 Dead/Cancelled
Textiles Nacionales no Tejidos, S.A. deC.V.
1994-04-28
UNIFIL
UNIFIL
73767367 1671561 Dead/Cancelled
IMPERIAL CHEMICAL INDUSTRIES PLC
1988-12-05
UNIFIL
UNIFIL
73707780 1567148 Dead/Cancelled
MIDWEST FILTRATION COMPANY
1988-01-26
UNIFIL
UNIFIL
73413670 1285780 Dead/Cancelled
Purdue Frederick Company, The
1983-02-15
UNIFIL
UNIFIL
73166567 1114914 Dead/Cancelled
W.R. GRACE & CO.
1978-04-17
UNIFIL
UNIFIL
72155248 0753581 Dead/Expired
HUMBLE OIL & REFINING COMPANY
1962-10-16
UNIFIL
UNIFIL
71649907 0587989 Live/Registered
SCULLY SIGNAL COMPANY
1953-07-06
UNIFIL
UNIFIL
71634502 0578554 Dead/Expired
UNIVERSAL WINDING COMPANY
1952-08-26

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