| Primary Device ID | 05902729752237 |
| NIH Device Record Key | 79e27cec-c284-4415-9e38-a54dbe627870 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Abutment Design |
| Version Model Number | 2017-1 (R1.1) |
| 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 | 05902729752237 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-30 |
| Device Publish Date | 2020-10-22 |
| 05902729753913 - Automate | 2024-01-30 Automate automatically generates designs and manufacturing files for certain dental CAD orders. |
| 05902729753845 - Implant Studio | 2023-08-04 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who h |
| 05902729753821 - Automate | 2023-04-05 The 3Shape Automate software is a web service for automatic design of crowns |
| 05902729753692 - Implant Studio | 2023-03-03 3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who h |
| 05902729752220 - Anatomy Design | 2022-02-21 Dental CAD Software |
| 05902729753531 - Puffin | 2021-06-08 The Puffin service is intended to aid in the design of dental restorative prosthetics. |
| 05902729752787 - Ortho System | 2021-06-04 CAD/CAM software |
| 05902729752954 - Splint Design | 2021-06-04 Dental treatment application software |