| Primary Device ID | E27667790080 |
| NIH Device Record Key | dadefc59-502a-4ef8-9a76-eff281f4ac61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-Smart Pro |
| Version Model Number | 6779008 |
| Catalog Number | 6779008 |
| 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 | false |
| 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 | |
| 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 | |
| Phone | +4962511670 |
| contact@dentsplysirona.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E27667790080 [Primary] |
| EKX | Handpiece, direct drive, ac-powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-06 |
| Device Publish Date | 2024-07-29 |
| E27667790160 | X-Smart Pro+ |
| E27667790080 | X-Smart Pro |