| Primary Device ID | D990RAMRU1PKBL20 |
| NIH Device Record Key | 9cda0cbd-7de4-4706-8884-f0650c8188c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rapid Arch Medium Round Upper 1PK, Shade BL2 |
| Version Model Number | RA-MRU1PK-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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D990RAMRU1PKBL20 [Primary] |
| EHY | Tray, Impression, Preformed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-11 |
| Device Publish Date | 2024-11-01 |
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