| Primary Device ID | 00860015217707 |
| NIH Device Record Key | a59d6d0a-1f41-40a5-99e7-708d51d881d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | enCore Night Guard |
| Version Model Number | Hybrid |
| Company DUNS | 128114843 |
| Company Name | ENCORE LABORATORY 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |