TOKUYAMA REBASE III

GUDID 04548190206612

Fast, Powder, Light Pink

TOKUYAMA DENTAL CORPORATION

Denture reliner, hard

• Primary Device ID: 04548190206612
• NIH Device Record Key: 832a8cda-90a6-461a-ac6b-e5e0dcb37d4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOKUYAMA REBASE III
• Version Model Number: 20661
• 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: 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: 1-877-378-3548
• 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	04548190206612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190940

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-05
• Device Publish Date: 2019-10-28

On-Brand Devices [TOKUYAMA REBASE III]

• 04548190206629: Liquid
• 04548190206612: Fast, Powder, Light Pink
• 04548190206605: Fast, Kit, Light Pink