| Primary Device ID | 00190707090326 |
| NIH Device Record Key | 43b442c1-7a32-4d1e-95f3-8182eb7d1be2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Risas Reveal® Aligners |
| Version Model Number | 133-AL32 |
| Company DUNS | 062165188 |
| Company Name | ORTHO ORGANIZERS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 00190707090326 [Primary] |
| NXC | Aligner, sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-22 |
| Device Publish Date | 2021-07-14 |
| 00190707090630 | Risas Reveal® Aligners Retainer Case |
| 00190707090623 | Risas Reveal® Aligners Sample Aligners |
| 00190707090616 | Risas Reveal® Aligners Sample Aligners |
| 00190707090609 | Risas Reveal® Aligners |
| 00190707090593 | Risas Reveal® Aligners |
| 00190707090586 | Risas Reveal® Aligners |
| 00190707090579 | Risas Reveal® Aligners |
| 00190707090562 | Risas Reveal® Aligners |
| 00190707090555 | Risas Reveal® Aligners |
| 00190707090548 | Risas Reveal® Aligners |
| 00190707090531 | Risas Reveal® Aligners |
| 00190707090524 | Risas Reveal® Aligners |
| 00190707090517 | Risas Reveal® Aligners |
| 00190707090500 | Risas Reveal® Aligners |
| 00190707090494 | Risas Reveal® Aligners |
| 00190707090487 | Risas Reveal® Aligners |
| 00190707090470 | Risas Reveal® Aligners |
| 00190707090463 | Risas Reveal® Aligners |
| 00190707090456 | Risas Reveal® Aligners |
| 00190707090449 | Risas Reveal® Aligners |
| 00190707090432 | Risas Reveal® Aligners |
| 00190707090425 | Risas Reveal® Aligners |
| 00190707090418 | Risas Reveal® Aligners |
| 00190707090401 | Risas Reveal® Aligners |
| 00190707090395 | Risas Reveal® Aligners |
| 00190707090388 | Risas Reveal® Aligners |
| 00190707090371 | Risas Reveal® Aligners |
| 00190707090364 | Risas Reveal® Aligners |
| 00190707090357 | Risas Reveal® Aligners |
| 00190707090340 | Risas Reveal® Aligners |
| 00190707090333 | Risas Reveal® Aligners |
| 00190707090326 | Risas Reveal® Aligners |
| 00190707090319 | Risas Reveal® Aligners |
| 00190707090302 | Risas Reveal® Aligners |
| 00190707090296 | Risas Reveal® Aligners |
| 00190707090289 | Risas Reveal® Aligners |
| 00190707090272 | Risas Reveal® Aligners |
| 00190707090265 | Risas Reveal® Aligners |
| 00190707090258 | Risas Reveal® Aligners |
| 00190707090241 | Risas Reveal® Aligners |
| 00190707090234 | Risas Reveal® Aligners |
| 00190707090227 | Risas Reveal® Aligners |
| 00190707090210 | Risas Reveal® Aligners |
| 00190707090203 | Risas Reveal® Aligners |
| 00190707090197 | Risas Reveal® Aligners |
| 00190707090180 | Risas Reveal® Aligners |
| 00190707090173 | Risas Reveal® Aligners |
| 00190707090166 | Risas Reveal® Aligners |
| 00190707090159 | Risas Reveal® Aligners |
| 00190707090142 | Risas Reveal® Aligners |