| Primary Device ID | E239D5048701 |
| NIH Device Record Key | 38024476-71b8-4443-8c26-feb98104d8f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StoneBite® scan |
| Version Model Number | D504870 |
| Catalog Number | D504870 |
| Company DUNS | 388000846 |
| Company Name | Dreve Dentamid 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +49230388070 |
| info@dreve.de |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E239D5048701 [Primary] |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-11-28 |
| Device Publish Date | 2016-10-07 |
| E239D38123US1 - Plaquit | 2024-04-24 No. |
| E239D38124US1 - Plaquit | 2024-04-24 No. |
| E239D38900US1 - NanoVarnish | 2023-10-24 No. |
| E239D3530011 - FotoDent® tray2 | 2023-04-26 No. |
| E239D3530021 - FotoDent® tray2 | 2023-04-26 No. |
| E239D3530031 - FotoDent® tray2 | 2023-04-26 No. |
| E239D38135N1 - Lightplast base plates | 2022-12-13 No. |
| E239D38135R1 - Lightplast base plates | 2022-12-13 No. |