| Primary Device ID | 00693856000043 |
| NIH Device Record Key | 86115946-6057-4620-a906-785098471841 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IS 3800 I/O 3D SCANNER |
| Version Model Number | 5943725 |
| Catalog Number | 5943725 |
| Company DUNS | 800111106 |
| Company Name | Dental Imaging Technologies Corporation |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00693856000043 [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 | 2023-06-02 |
| Device Publish Date | 2023-05-25 |
| D090100879340 - DEXIS 10 (DEXIS Imaging Suite) | 2024-03-20 |
| D090800025750 - DEXIS Ti2 Sensor Kit | 2024-01-31 DEXIS Ti2 Kit, EN FR-CA |
| D090800025780 - DEXIS Ti2 Sensor Kit | 2024-01-31 DEXIS Ti2 Warranty Replacement NEW |
| D090800025790 - DEXIS Ti2 Sensor Kit | 2024-01-31 Upgrade Kit, Sensor to Ti2 |
| D090800025800 - DEXIS Ti2 Sensor Kit | 2024-01-31 DEXIS Ti2 Warranty Replacement - R |
| D090800025840 - DEXIS Ti2 Sensor Kit | 2024-01-31 Upgrade Kit, Platinum to Ti2 |
| 00693856000302 - CS MODEL+ | 2023-12-21 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY |
| D090800025720 - DEXIS Ti2 Sensor | 2023-12-20 |