GC CAVITY CONDITIONER 000110

GUDID 24548161282496

GC CAVITY CONDITIONER 5.7 mL Liquid

Gc America Inc.

Dental etching solution
Primary Device ID24548161282496
NIH Device Record Key707bad62-0fd8-4e57-aa90-287a2d85965b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGC CAVITY CONDITIONER
Version Model Number000110
Catalog Number000110
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 Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter
Total Volume5.7 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS114548161282499 [Primary]
GS124548161282496 [Package]
Contains: 14548161282499
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

Devices Manufactured by Gc America Inc.

D0470095414 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45 regular mixing tips, 5 endo mix
D0470095534 - G-Multi PRIMER2025-03-17 G-Multi PRIMER 5mL, 1 btl. 5mL
D0470101184 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bottle G-Multi Primer 5mL, 20 regul
D0470101194 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ Starter Kit Translucent, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bottle G-Multi Primer 5mL,
D0470101204 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ Cement Refill A2, 1 syringe (8.7g/5mL), 20 regular mixing tips
D0470101214 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ Cement Refill Translucent, 1 syringe (8.7g/5mL), 20 regular mixing tips
D0470101224 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ Cement Refill Opaque, 1 syringe (8.7g/5mL), 20 regular mixing tips
D0470101234 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips
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