| Primary Device ID | 05902729753821 |
| NIH Device Record Key | 9f225a41-25a0-4654-8f34-248b71416f89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Automate |
| Version Model Number | R1.2 |
| Company DUNS | 306826012 |
| Company Name | 3shape 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05902729753821 [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 | 2023-04-05 |
| Device Publish Date | 2023-03-28 |
| 05902729753821 | The 3Shape Automate software is a web service for automatic design of crowns |
| 05902729753913 | Automate automatically generates designs and manufacturing files for certain dental CAD orders. |
| 05902729754019 | Automate is intended to generate design and manufacturing files for dental restorative prostheti |