| Primary Device ID | E23511810 |
| NIH Device Record Key | 935de28d-f456-4ff5-be08-c100658b3c08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZOE Temporary Powder 20g (SDC Catalogue) |
| Version Model Number | 1181 |
| Catalog Number | 1181 |
| 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 | E23511810 [Primary] |
| EMA | Cement, Dental |
| 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 | 2016-09-26 |
| E235S3DCR0 - Dentaprint | 2025-09-03 Dentaprint 3D Cast Resin Sample |
| E235S3DMR0 - Dentaprint | 2025-09-03 Dentaprint 3D Model Resin Sample |
| E235S3DOR0 - Dentaprint | 2025-09-03 Dentaprint 3D Ortho Model Resin Sample |
| E235S3DSGR0 - Dentaprint | 2025-09-03 Dentaprint 3D Surgical Guide Resin Sample |
| E235S3DTIR0 - Dentaprint | 2025-09-03 Dentaprint 3D Try-In Resin (A1) Sample |
| E23596220 - VINTAGE GUMMY SHADE GUIDE | 2025-08-01 Dental Shade Guide |
| E235IEWK0 - INCISAL EDGE WEAR KIT | 2024-10-24 IEWK (INCISAL EDGE WEAR KIT) Contains: Beautibond Bulk (E23517820), One Gloss PS IC (Bulk) In Pouch (E23501780). One Gloss PS |
| E235Y23510 - Beautifil Flow Plus X | 2024-10-15 BEAUTIFIL FLOW PLUS X APPLICATION TIPS (50 units) |