G-CEM LinkForce™ 010123

GUDID D0470101234

G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips

Gc America Inc.

Dental composite resin
Primary Device IDD0470101234
NIH Device Record Keye2217ee3-6136-4b2c-977e-9a0d875e8a6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameG-CEM LinkForce™
Version Model Number010123
Catalog Number010123
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
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in refrigerator
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 46 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0470101231 [Primary]
HIBCCD0470101234 [Package]
Contains: D0470101231
Package: Carton [16 Units]
In Commercial Distribution

FDA Product Code

EMACEMENT, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-03-17
Device Publish Date2016-10-20

On-Brand Devices [G-CEM LinkForce™]

D0470095514G-CEM LinkForce™ Try-In Paste Bleach, 1 syringe (1.5g/1.2mL)
D0470095504G-CEM LinkForce™ Try-In Paste Opaque 1 syringe (1.5g/1.2mL)
D0470095494G-CEM LinkForce™ Try-In Paste Translucent 1 syringe (1.5g/1.2mL)
D0470095484G-CEM Link Force™ Try-In Paste A2, 1 syringe (1.5g/1.2mL)
14548161292504G-CEM Try-In Paste Bleach Refill Syringe, 3 disensing tips (metal type), 1 tip cover
14548161292498G-CEM Try-In Paste Opaque Refill Syringe, 3 dispensing tips (metal type), 1 tip cover
14548161292481G-CEM Try-In Paste Translucent Refill Syringe, 3 Dispensing tips (metal type) 1 tip cover
14548161292474G-CEM Try-In Paste A2 Refill Syringe, 3 dispensing tips (metal type), 1 tip cover
44548161321892G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips
44548161321885G-CEM LinkForce™ Cement Refill Opaque, 1 syringe (8.7g/5mL), 20 regular mixing tips
44548161321878G-CEM LinkForce™ Cement Refill Translucent, 1 syringe (8.7g/5mL), 20 regular mixing tips
44548161321861G-CEM LinkForce™ Cement Refill A2, 1 syringe (8.7g/5mL), 20 regular mixing tips
44548161321854G-CEM LinkForce™ Starter Kit Translucent, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5
44548161321847G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bot
44548161321830G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45
D04710128031G-CEM Try-In Paste A2 Refill Syringe, 3 dispensing tips (metal type), 1 tip cover
D0470128061G-CEM Try-In Paste Bleach Refill Syringe, 3 disensing tips (metal type), 1 tip cover
D0470128051G-CEM Try-In Paste Opaque Refill Syringe, 3 dispensing tips (metal type), 1 tip cover
D0470128041G-CEM Try-In Paste Translucent Refill Syringe, 3 Dispensing tips (metal type) 1 tip cover
D0470101234G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips
D0470101224G-CEM LinkForce™ Cement Refill Opaque, 1 syringe (8.7g/5mL), 20 regular mixing tips
D0470101214G-CEM LinkForce™ Cement Refill Translucent, 1 syringe (8.7g/5mL), 20 regular mixing tips
D0470101204G-CEM LinkForce™ Cement Refill A2, 1 syringe (8.7g/5mL), 20 regular mixing tips
D0470101194G-CEM LinkForce™ Starter Kit Translucent, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5
D0470101184G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bot
D0470095414G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45

Trademark Results [G-CEM LinkForce]

Mark Image

Registration | Serial
Company
Trademark
Application Date
G-CEM LINKFORCE
G-CEM LINKFORCE
85754860 5124527 Live/Registered
GC Corporation
2012-10-16

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