| Primary Device ID | EKAV101261800 |
| NIH Device Record Key | bd250b2f-4f7b-4460-8496-1a1ed5eb9a64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEXIS Titanium Intraoral X-Ray Sensor |
| Version Model Number | 1.012.6180 |
| Company DUNS | 800111106 |
| Company Name | Imaging Sciences International |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
|---|---|
| HIBCC | EKAV101261800 [Primary] |
| MUH | System, X-Ray, Extraoral Source, Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-31 |
| Device Publish Date | 2022-01-21 |
| EKAV083081000 - KaVo OP 3D Vision | 2022-01-31 V8 |
| EKAV083082000 - KaVo OP 3D Vision | 2022-01-31 V10 |
| EKAV083083000 - KaVo OP 3D Vision | 2022-01-31 V17 |
| EKAV085006210 - NOMAD Pro2 Packaged X-Ray System - R | 2022-01-31 |
| EKAV085006220 - NOMAD Pro2 Packaged X-Ray System Black-R | 2022-01-31 |
| EKAV101261800 - DEXIS Titanium Intraoral X-Ray Sensor | 2022-01-31 |
| EKAV101261800 - DEXIS Titanium Intraoral X-Ray Sensor | 2022-01-31 |
| EKAV101261810 - KaVo IXS Size 1, Intra-Oral X-Ray Sensor | 2022-01-31 |
| EKAV101261820 - KaVo IXS Size 2, Intra-Oral X-Ray Sensor | 2022-01-31 |