| Primary Device ID | E23511760 |
| NIH Device Record Key | c0df61d4-8106-4cc2-b891-30438d729239 |
| Commercial Distribution Discontinuation | 2020-11-30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HY-Temporary Soft |
| Version Model Number | 1176 |
| Catalog Number | 1176 |
| 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 | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com | |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E23511760 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-16 |
| Device Publish Date | 2016-09-23 |
| 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 |
| 14548162335460 - ROBOT POINTS PRO-CUT | 2024-09-12 ROBOT POINTS PRO-CUT FG D006EF 5pcs |
| 14548162335477 - ROBOT POINTS PRO-CUT | 2024-09-12 ROBOT POINTS PRO-CUT FG D007EF 5pcs |
| 14548162335484 - ROBOT POINTS PRO-CUT | 2024-09-12 ROBOT POINTS PRO-CUT FG D010EF 5pcs |
| 14548162335491 - ROBOT POINTS PRO-CUT | 2024-09-12 ROBOT POINTS PRO-CUT FG D027EF 5pcs |
| 14548162335507 - ROBOT POINTS PRO-CUT | 2024-09-12 ROBOT POINTS PRO-CUT FG D053EF 5pcs |
| 14548162335514 - ROBOT POINTS PRO-CUT | 2024-09-12 ROBOT POINTS PRO-CUT FG D054EF 5pcs |
| 14548162335521 - ROBOT POINTS PRO-CUT | 2024-09-12 ROBOT POINTS PRO-CUT FG D055EF 5pcs |