MI Paste™ 424505

GUDID 20386040008706

MI Paste™ 10-pack, 10 tubes (40g each) Strawberry only

Gc America Inc.

Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional

• Primary Device ID: 20386040008706
• NIH Device Record Key: aeda09cc-d40e-44da-ab8d-e3ccc891079a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MI Paste™
• Version Model Number: 424505
• Catalog Number: 424505
• 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: true
• 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@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040008709 [Primary]
GS1	20386040008706 [Package]; Contains: 10386040008709; Package: [30 Units]; In Commercial Distribution

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: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [MI Paste™]

• 20386040008706: MI Paste™ 10-pack, 10 tubes (40g each) Strawberry only
• 20386040008676: MI Paste™ 10 tubes (40g each) Mint only
• 20386040008584: MI Paste™ 10-pack, 10 tubes (40g each) of MI Paste Assorted has 2 tubes of each flavor (melon,