| Primary Device ID | E23520860 |
| NIH Device Record Key | 9cb0019a-2d95-41e5-84d0-277e573f5f49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal Opaque |
| Version Model Number | 2086 |
| Catalog Number | 2086 |
| 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 |
| Storage Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E23520860 [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 | 4 |
| Public Version Date | 2018-07-24 |
| Device Publish Date | 2016-09-23 |
| E23521110 | Universal Opaque Pre-Opaque |
| E23521100 | Universal Opaque P0 |
| E23521090 | Universal Opaque VR0 |
| E23521080 | Universal Opaque VP0 |
| E23521070 | Universal Opaque IN0 |
| E23521060 | Universal Opaque MO |
| E23521050 | Universal Opaque G0 |
| E23521040 | Universal Opaque BG0 |
| E23521030 | Universal Opaque GUM0 |
| E23521020 | Universal Opaque W30 |
| E23521010 | Universal Opaque W20 |
| E23521000 | Universal Opaque WO |
| E23520990 | Universal Opaque R3.50 |
| E23520980 | Universal Opaque R30 |
| E23520970 | Universal Opaque R20 |
| E23520960 | Universal Opaque ROOTAO |
| E23520950 | Universal Opaque D40 |
| E23520940 | Universal Opaque D30 |
| E23520930 | Universal Opaque D20 |
| E23520920 | Universal Opaque C40 |
| E23520910 | Universal Opaque C30 |
| E23520900 | Universal Opaque C20 |
| E23520890 | Universal Opaque C10 |
| E23520880 | Universal Opaque B40 |
| E23520870 | Universal Opaque B30 |
| E23520860 | Universal Opaque B20 |
| E23520850 | Universal Opaque B10 |
| E23520840 | Universal Opaque A40 |
| E23520830 | Universal Opaque A3.50 |
| E23520820 | Universal Opaque A30 |
| E23520810 | Universal Opaque A20 |
| E23520800 | Universal Opaque A10 |