| Primary Device ID | E23511620 |
| NIH Device Record Key | c4428028-6511-4341-80c8-06d54e71ebc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polycarboxylate |
| Version Model Number | 1162 |
| Catalog Number | 1162 |
| 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 |