| Primary Device ID | D82852000280 |
| NIH Device Record Key | 3e1cff53-0a16-4753-a98f-56b25b0aeb70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EMA |
| Version Model Number | 5200028 |
| Company DUNS | 113352686 |
| Company Name | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| 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 |