TRIOS Ready Tip

GUDID 05902729753906

3shape Trios A/S

Intraoral optical scanning system

• Primary Device ID: 05902729753906
• NIH Device Record Key: 333f47f3-b0b4-4542-bb8a-00448e08e1bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIOS Ready Tip
• Version Model Number: TST-15
• Company DUNS: 305225025
• Company Name: 3shape Trios A/S
• Device Count: 25
• 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: true
• 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: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902729753906 [Primary]
GS1	05902729754125 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242103

FDA Product Code

• NBL: Laser, Fluorescence Caries Detection

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: 2025-05-14
• Device Publish Date: 2025-05-06

Devices Manufactured by 3shape Trios A/S

• 05902729754149 - TRIOS 5: 2025-06-24 The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
• 05902729753906 - TRIOS Ready Tip: 2025-05-14
• 05902729753906 - TRIOS Ready Tip: 2025-05-14
• 05902729753982 - TRIOS 6: 2025-05-02
• 05902729754088 - TRIOS® 3: 2025-04-09 Scanner tip w. mirror (autoclavable)
• 05902729754057 - TRIOS Patient Monitoring: 2024-11-07 The TRIOS Patient Monitoring software can be used for the visualization and comparison of 3D scans of the dentition.
• 05902729753852 - TRIOS 3: 2024-05-27 Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner
• 05902729753869 - TRIOS 3: 2024-05-27 Color pen-grip intraoral scanner w. protection tip
• 05902729753876 - TRIOS Core: 2024-05-27 Color pen-grip intraoral scanner w. protection tip