| Primary Device ID | D990RAMRL1PKBL20 |
| NIH Device Record Key | 049dccbd-358b-412d-b11b-dd3f4ca98352 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rapid Arch Large Round Lower 1PK, Shade BL2 |
| Version Model Number | RA-LRL1PK-BL2 |
| Company DUNS | 010613514 |
| Company Name | Smart Denture Conversions, LLC |
| 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 | 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 |