| Primary Device ID | E23565610 |
| NIH Device Record Key | 174d033e-d4c6-4b96-bd6e-9fc3ce65ad96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Porcelain Stain Liquid medium |
| Version Model Number | 6561 |
| Catalog Number | 6561 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E23565610 [Primary] |
| EIH | Powder, Porcelain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2016-09-26 |
| 84548162303703 - BEAUTIFIL Needle Tips | 2025-12-23 BEAUTIFIL Needle Tips 18G 50pcs |
| 84548162303710 - BEAUTIFIL Needle Tips | 2025-12-23 BEAUTIFIL Needle Tips 20G 50pcs |
| 84548162303727 - BEAUTIFIL Needle Tips | 2025-12-23 BEAUTIFIL Needle Tips 20G-L 50pcs |
| 84548162303734 - BeautiSealant Needle Tips | 2025-12-23 BeautiSealant Needle Tips 23G 50pcs |
| 84548162303741 - BeautiSealant Needle Tips | 2025-12-23 BeautiSealant Needle Tips 27G 50pcs |
| 04548162310439 - BEAUTIFIL II | 2025-12-17 BEAUTIFIL II 4.5g A1 Syringe 1pc |
| 04548162310446 - BEAUTIFIL II | 2025-12-17 BEAUTIFIL II 4.5g A2 Syringe 1pc |
| 04548162310453 - BEAUTIFIL II | 2025-12-17 BEAUTIFIL II 4.5g A2O Syringe 1pc |