| 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 |