| Primary Device ID | 05902729753654 | 
| NIH Device Record Key | 62b3adb4-ee1a-417e-85be-eeb97540cf76 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Automate | 
| Version Model Number | R1.0 | 
| Company DUNS | 305225025 | 
| Company Name | 3shape Trios A/S | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | 
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | |
| Phone | +4570272620 | 
| support@3shape.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05902729753654 [Primary] | 
| PNN | Orthodontic Software | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-06-08 | 
| Device Publish Date | 2021-05-31 | 
| 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 | 
| 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 |