| Primary Device ID | D7075820740 |
| NIH Device Record Key | 1e9ecd8b-facc-4cd1-9ac7-76bde3835239 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Harmony Hard |
| Version Model Number | 582074 |
| Catalog Number | 582074 |
| Company DUNS | 176935203 |
| Company Name | IVOCLAR VIVADENT, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |