| Primary Device ID | E27659638500 |
| NIH Device Record Key | c956f1ed-6ef6-4bff-ac90-b776ae7469e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOPHOS XG |
| Version Model Number | 5963850 |
| Company DUNS | 340306351 |
| Company Name | SIRONA Dental Systems GmbH |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27659638500 [Primary] |
| EHD | Unit, X-Ray, Extraoral With Timer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-10 |
| E27663000290 | ORTHOPHOS XG 3D CEPH |
| E27664316670 | ORTHOPHOS XG 3D Ceph |
| E27664316590 | ORTHOPHOS XG 3D |
| E27663688360 | TF XG plus TSA/Ceph -> XG3D, 3D upgrade kit for a 2D device |
| E27663626490 | 3D ready --> 3D, 3D upgrade kit for a 2D device |
| E27663313210 | TF XG5 -> XG3D, 3D upgrade kit for a 2D device |
| E27663313130 | TF XG Plus -> XG3D, 3D upgrade kit for a 2D device |
| E27663000110 | ORTHOPHOS XG 3D |
| E27662812520 | ORTHOPHOS XG 3D ready |
| E27662812450 | ORTHOPHOS XG 3D ready Ceph |
| E27662812370 | ORTHOPHOS XG 5 Ceph/ XG 5DS Ceph |
| E27662812290 | ORTHOPHOS XG 5 / XG 5DS |
| E27662372390 | ORTHOPHOS XG 3 |
| E27660055860 | ORTHOPHOS XG 3 |
| E27659934020 | Cephalometer retrofit left / right |
| E27659933940 | ORTHOPHOS XG 5 / XG 5DS |
| E27659933860 | ORTHOPHOS XG 5 Ceph/XG 5DS Ceph |
| E27659638680 | ORTHOPHOS XG 3D ready Ceph |
| E27659638500 | ORTHOPHOS XG 3D ready |