Sofreliner Tough

GUDID 04548190233519

M Kit

TOKUYAMA DENTAL CORPORATION

Denture reliner, elastic, long-term

• Primary Device ID: 04548190233519
• NIH Device Record Key: 70cc3afa-fd19-4037-8ea2-3f8001a05bc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sofreliner Tough
• Version Model Number: 23351
• Company DUNS: 693552176
• Company Name: TOKUYAMA DENTAL CORPORATION
• 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: true
• 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: 1-877-378-3548
• Email: info@tokuyama-us.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548190233519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030663

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-09-23

On-Brand Devices [Sofreliner Tough]

• 04548190234417: Primer
• 04548190234110: S Paste
• 04548190234011: S Kit
• 04548190233564: M Paste
• 04548190233519: M Kit