| Primary Device ID | E23514640 |
| NIH Device Record Key | d00fa731-5d22-4cd2-9fa2-d4b18fd49119 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Beautifil Flow |
| Version Model Number | 1464 |
| Catalog Number | 1464 |
| Company DUNS | 054618202 |
| Company Name | SHOFU DENTAL CORPORATION |
| 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 | 760-566-3528 |
| ckaemmerlen@shofu.com |
| Handling Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E23514640 [Primary] |
| 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 | 2016-09-24 |
| E23514820 | BEAUTIFIL FLOW 2g T HIGH FLOW |
| E23514790 | BEAUTIFIL FLOW 2g A3O HIGH FLOW |
| E23514650 | BEAUTIFIL FLOW 2g A4 HIGH FLOW |
| E23514640 | BEAUTIFIL FLOW 2g A3.5 HIGH FL |
| E23514630 | BEAUTIFIL FLOW 2g A3 HIGH FLOW |
| E23514620 | BEAUTIFIL FLOW 2g A2 HIGH FLOW |
| E23514610 | BEAUTIFIL FLOW 2g A1 HIGH FLOW |
| E23514510 | BEAUTIFIL FLOW 2g G LOW FLOW |
| E23514490 | BEAUTIFIL FLOW 2g A3O LOW FLOW |
| E23514350 | BEAUTIFIL FLOW 2g A4 LOW FLOW |
| E23514340 | BEAUTIFIL FLOW 2g A3.5 LOW FLOW |
| E23514330 | BEAUTIFIL FLOW 2g A3 LOW FLOW |
| E23514320 | BEAUTIFIL FLOW 2g A2 LOW FLOW |
| E23514310 | BEAUTIFIL FLOW 2g A1 LOW FLOW |