Tokuso Resin Hardner II

GUDID 04548190201716

TOKUYAMA DENTAL CORPORATION

Denture reliner, hard

• Primary Device ID: 04548190201716
• NIH Device Record Key: 8ac540a4-e8a1-4ffd-aae0-ea3578d1a4c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tokuso Resin Hardner II
• Version Model Number: 20171
• 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: 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: 1-877-378-3548
• 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	04548190201716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022641

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 [Tokuso Resin Hardner II]

• 04548190201716: 20171
• 04548190201723: 20172