Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)

GUDID 00827854027126

Gentle Mint

TOM'S OF MAINE, INC.

Dental cavity varnish

• Primary Device ID: 00827854027126
• NIH Device Record Key: 18c616cc-475d-434c-9627-f9e283da48b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)
• Version Model Number: 61053729
• Company DUNS: 829517189
• Company Name: TOM'S OF MAINE, 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-367-8667
• Email: xx@xx.xx
• Phone: 1-800-367-8667
• Email: xx@xx.xx
• Phone: 1-800-367-8667
• Email: xx@xx.xx
• Phone: 1-800-367-8667
• Email: xx@xx.xx
• Phone: 1-800-367-8667
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827854027126 [Package]; Contains: 20827854027120; Package: Carton [1 Units]; In Commercial Distribution
GS1	10827854027123 [Package]; Package: Case [24 Units]; In Commercial Distribution
GS1	20827854027120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103461

FDA Product Code

• LBH: Varnish, 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: 2025-12-23
• Device Publish Date: 2025-12-15