| Primary Device ID | 04548190127382 |
| NIH Device Record Key | 2fe146a1-b79c-4de5-882f-3c745745a167 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Estelite Bulk Fill Flow |
| Version Model Number | 12738 |
| Company DUNS | 693552176 |
| Company Name | TOKUYAMA DENTAL CORPORATION |
| Device Count | 20 |
| 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 | true |
| 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 | 1-877-378-3548 |
| info@tokuyama-us.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548190127382 [Primary] |
| GS1 | 94548190127385 [Unit of Use] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-01 |
| 04548190127443 | PLT Mini Kit |
| 04548190127399 | PLT A3 |
| 04548190127382 | PLT A2 |
| 04548190127375 | PLT A1 |
| 04548190127368 | PLT B1 |
| 04548190127351 | PLT U |
| 04548190127191 | Syringe A3 |
| 04548190127184 | Syringe A2 |
| 04548190127177 | Syringe A1 |
| 04548190127160 | Syringe B1 |
| 04548190127153 | Syringe U |