| Primary Device ID | EKAV100879340 |
| NIH Device Record Key | 2833d196-ac29-44a1-9768-90dfc50fa217 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEXIS 10 (DEXIS Imaging Suite) |
| Version Model Number | 10 |
| Catalog Number | 1.008.7934 |
| Company DUNS | 019717844 |
| Company Name | DEXIS LLC |
| 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 | true |
| Serial Number | false |
| 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 |
|---|---|
| HIBCC | EKAV100879340 [Primary] |
| LLZ | System, Image Processing, Radiological |
| 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 |
| EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite) | 2022-01-31 |
| EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite) | 2022-01-31 |
| EKAV101244750 - DEXIS™ Software | 2021-11-22 Software |
| EKAV101289030 - DEXcam3™ intraoral cameras | 2021-11-22 Digital intraoral camera |
| EKAV101289070 - DEXcam3™ intraoral cameras | 2021-11-22 Digital intraoral camera |
| EKAV082250710 - DEXIS Platinum™ intraoral sensor | 2018-07-06 Digital intraoral sensor |
| EKAV082250730 - DEXIS Platinum™ intraoral sensor | 2018-07-06 Digital intraoral sensor |
| EKAV082250740 - DEXIS Platinum™ intraoral sensor | 2018-07-06 Digital intraoral sensor |
| EKAV082251940 - DEXIS Platinum™ intraoral sensor | 2018-07-06 Digital intraoral sensor |