| Primary Device ID | 00850078989338 |
| NIH Device Record Key | 9266ab74-0738-448b-85a3-2495d0ffaf56 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmileSet Impression Kit |
| Version Model Number | 110-0101 |
| Company DUNS | 119338749 |
| Company Name | Ortho Dental Lab LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | true |