| Primary Device ID | E27664649810 |
| NIH Device Record Key | 4cfcda84-b5e1-4e33-9863-9c04c3c41b9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOPHOS SL |
| Version Model Number | 6464981 |
| 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 |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com | |
| Phone | +4962511670 |
| contact@dentsplysirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27664649810 [Primary] |
| OAS | X-Ray, Tomography, Computed, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-24 |
| Device Publish Date | 2016-09-10 |
| E27664734380 | Ceph SL arm right cpl. |
| E27664731230 | Ceph SL arm left cpl. |
| E27664664400 | OP SL 3D individ. |
| E27664649990 | OP SL 3D 11x10 DCS |
| E27664649810 | OP SL 3D 11x10 |
| E27664649730 | OP SL 3D 8x8 DCS |
| E27664649650 | OP SL 3D 8x8 |
| E27664649570 | OP SL 2D |
| E27664403950 | OP SL 2D individ. |