GC Tooth Mousse 10004557

GUDID 10386040015233

GC Tooth Mousse Plus

Gc America Inc.

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• Primary Device ID: 10386040015233
• NIH Device Record Key: 004566ab-eee2-4e2c-849b-3cee96af55fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Tooth Mousse
• Version Model Number: 10004557
• Catalog Number: 10004557
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com
• Phone: +1(708)597-0900
• Email: customerservice@gca.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040015233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042200

FDA Product Code

• EJR: AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-15
• Device Publish Date: 2024-03-07

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• 20386040015247 - Foundation: 2024-03-20 Collagen-Based Bone Filling Augmentation Material
• 20386040015254 - Foundation: 2024-03-20 Collagen-Based Bone Filling Augmentation Material
• 10386040015233 - GC Tooth Mousse: 2024-03-15GC Tooth Mousse Plus
• 10386040015233 - GC Tooth Mousse: 2024-03-15 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