Tuf-Link II TK-102

GUDID 07350081494810

TUF-LINK 10 ml syringe Silicone Material incl. 3 mixing tips for TK-G-10 Dispenser Gun

Dentatus AB

Denture reliner, elastic, long-term

• Primary Device ID: 07350081494810
• NIH Device Record Key: 738b5041-dd12-454d-80bf-ec07b5573d5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuf-Link II
• Version Model Number: TK-102
• Catalog Number: TK-102
• Company DUNS: 355803412
• Company Name: Dentatus AB
• 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: true
• 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: +12124811010
• Email: dentatus@dentatus.se

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350081494810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042931

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: 2016-08-10

On-Brand Devices [Tuf-Link II]

• 07350081494827: TUF-LINK 50 ml syringe Silicone Material incl. 10 mixing tips for TK-G Dispenser Gun.
• 07350081494810: TUF-LINK 10 ml syringe Silicone Material incl. 3 mixing tips for TK-G-10 Dispenser Gun