| Primary Device ID | D0026425021 |
| NIH Device Record Key | 481a776b-7485-4895-ba60-ca0dbf0543f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Class II Approach |
| Version Model Number | 642502 |
| Catalog Number | 642502 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |