| Primary Device ID | 00693856000005 |
| NIH Device Record Key | 96905da4-17cb-4fc0-9b60-d1a64768efef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IS 3600 I/O 3D Scanner |
| Version Model Number | 6568745 |
| Catalog Number | 6568745 |
| 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 | 00693856000005 [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 | 2022-09-14 |
| Device Publish Date | 2022-09-06 |
| D090101289030 - DEXcam4 HD | 2025-12-19 |
| 00693856000159 - Assembly-IS 3600 SIDE TIP | 2025-12-12 |
| 00693856000173 - Assembly-IS 3600 POSTERIOR TIP | 2025-12-12 |
| 00693856000197 - Assembly-IS 3700 NORMAL TIP | 2025-12-12 |
| 00693856000203 - Assembly-IS 3700 SIDE TIP | 2025-12-12 |
| 00693856000227 - Assembly-IS 3700 POSTERIOR TIP | 2025-12-12 |
| 00693856000258 - Assembly-IS 3800 NORMAL TIP | 2025-12-12 |
| 00693856000272 - Assembly-IS 3800 SIDE TIP | 2025-12-12 |