| Primary Device ID | ESDG6247801 |
| NIH Device Record Key | 0b645841-7cdc-4a8e-9fe2-f870906fe946 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tizian Ceramic Opaquer Fluid LO |
| Version Model Number | 624780 |
| Company DUNS | 315830349 |
| Company Name | Schütz Dental 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 |
| Storage Environment Temperature | Between 12 Degrees Celsius and 38 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | ESDG6247801 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2016-09-08 |
| ESDG6247811 | Dental glass ceramic material, colored to match the VITAPAN® color system. It is used for the c |
| ESDG6247801 | Dental glass ceramic material, colored to match the VITAPAN® color system. It is used for the c |
| ESDG6247791 | Dental glass ceramic material, colored to match the VITAPAN® color system. It is used for the c |