GC Tooth Mousse 10004557

GUDID 10386040015233

GC Tooth Mousse Plus

Gc America Inc.

Dental coating, tooth-desensitizing, professional
Primary Device ID10386040015233
NIH Device Record Key004566ab-eee2-4e2c-849b-3cee96af55fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameGC Tooth Mousse
Version Model Number10004557
Catalog Number10004557
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 Datefalse
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@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com
Phone+1(708)597-0900
Emailcustomerservice@gca.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 8 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110386040015233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-15
Device Publish Date2024-03-07

Devices Manufactured by Gc America Inc.

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20386040015247 - Foundation2024-03-20 Collagen-Based Bone Filling Augmentation Material
20386040015254 - Foundation2024-03-20 Collagen-Based Bone Filling Augmentation Material
10386040015233 - GC Tooth Mousse2024-03-15GC Tooth Mousse Plus
10386040015233 - GC Tooth Mousse2024-03-15 GC Tooth Mousse Plus
D0470000631 - UniFil®2024-02-16 UniFil® 6 mL self-etching primer liquid
D0470000641 - UniFil®2024-02-16 UniFil® 6 mL bonding agent liquid

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