| Primary Device ID | E23511600 |
| NIH Device Record Key | c5f1d7b5-e79b-49c8-9296-4a167494dbf7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HY-Bond Polycarboxylate Cement |
| Version Model Number | 1160 |
| Catalog Number | 1160 |
| 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 | E23511600 [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 | 2016-09-23 |
| E235D18A1ML0 - DENTADISC | 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A1. ML |
| E235D18A1MN0 - DENTADISC | 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A1. MN |
| E235D18A2ML0 - DENTADISC | 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm A2. ML |
| E235D18A2MN0 - DENTADISC | 2026-02-02 DentaDisc CAD/CAM DISC. 98.5X18mm A2. MN |
| E235D18A35MN0 - DENTADISC | 2026-02-02 PORTUX CAD/CAM DISC. 98.5 x18mm A3.5. MN |
| E235D18A3ML0 - DENTADISC | 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm A3. ML |
| E235D18A3MN0 - DENTADISC | 2026-02-02 DentaDisc CAD/CAM DISC. 98.5 x18mm A3. MN |
| E235D18B1ML0 - DENTADISC | 2026-02-02 PORTUX CAD/CAM DISC. 98.5X18mm B1. ML |