| Primary Device ID | D080SSCPXO61SXUXB40 |
| NIH Device Record Key | 675486b8-4be6-4d7a-b547-8f65aa8d9bf6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CROWN PX |
| Version Model Number | 6*1SET,O61S,U,B4 |
| Company DUNS | 693430001 |
| Company Name | YAMAHACHI DENTAL MFG.,CO. |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |