| Primary Device ID | 08800017902098 |
| NIH Device Record Key | db26bd7c-bd2c-4db5-b4e0-4e5dc9c15c45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Impression Bite Tray |
| Version Model Number | Quadrant |
| Catalog Number | [BT-3000] |
| Company DUNS | 688797315 |
| Company Name | DXM CO., 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |