| Primary Device ID | E23514190 |
| NIH Device Record Key | 25c06545-1b82-4380-8e8c-36b825323a79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Beautifil II |
| Version Model Number | 1419 |
| Catalog Number | 1419 |
| 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 | E23514190 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| E235BIIK30 | Beautifil II Refill Tips Shade A1 BurButler Kit . Contains DI: E23517520 |
| E235BIIK20 | Beautifil II Refill Tips Shade A3 BurButler Kit . Contains DI: E23517540 |
| E235BIIK10 | Beautifil II Refill Tips Shade A2 BurButler Kit . Contains DI: E23517530 |
| E23517770 | BEAUTIFIL II COSMETIC KIT |
| E23517750 | BEAUTIFIL II 6 COLOR SET |
| E23517710 | A30 BEAUTIFIL II REFILL TIPS |
| E23517700 | A2O BEAUTIFIL II REFILL TIPS |
| E23517670 | BW BEAUTIFIL II REFILL TIPS |
| E23517660 | INC BEAUTIFIL II REFILL TIPS |
| E23517630 | C2 BEAUTIFIL II REFILL TIPS |
| E23517600 | B2 BEAUTIFIL II REFILL TIPS |
| E23517590 | B1 BEAUTIFIL II REFILL TIPS |
| E23517560 | A4 BEAUTIFIL II REFILL TIPS |
| E23517550 | A3.5 BEAUTIFIL II REFILL TIPS |
| E23517540 | A3 BEAUTIFIL II REFILL TIPS |
| E23517530 | A2 BEAUTIFIL II REFILL TIPS |
| E23517520 | A1 BEAUTIFIL II REFILL TIPS |
| E23514200 | BEAUTIFIL II A3O |
| E23514190 | BEAUTIFIL II A2O |
| E23514160 | BEAUTIFIL II BW |
| E23514150 | BEAUTIFIL II INC |
| E23514130 | BEAUTIFIL II C3 |
| E23514120 | BEAUTIFIL II C2 |
| E23514100 | BEAUTIFIL II B3 |
| E23514090 | BEAUTIFIL II B2 |
| E23514080 | BEAUTIFIL II B1 |
| E23514050 | BEAUTIFIL II A4 |
| E23514040 | BEAUTIFIL II A3.5 |
| E23514030 | BEAUTIFIL II A3 |
| E23514020 | BEAUTIFIL II A2 |
| E23514010 | BEAUTIFIL II A1 |
| E235Y17520 | A1 BEAUTIFIL II BULK |
| E23517760 | BEAUTIFIL II TIP 6 COLOR SET |
| E2351753B0 | BEAUTIFIL II TIPS BULK |