| Primary Device ID | D9560GFXBIO0 |
| NIH Device Record Key | 676e91e4-3ba0-439e-9661-f9eda32fafca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glass-FX Bio |
| Version Model Number | GFX-BIO |
| Company DUNS | 532290720 |
| Company Name | D.S.I DENTAL SOLUTIONS LTD |
| 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 | true |
| 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 |