| Primary Device ID | 00190707096984 |
| NIH Device Record Key | 0916154f-da49-43f7-9c9b-6bb88803609a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Direct Bond Retainer |
| Version Model Number | 433-022 |
| Company DUNS | 062165188 |
| Company Name | Ortho Organizers, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | 00190707096984 [Primary] |
| EJF | BRACKET, METAL, ORTHODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-19 |
| Device Publish Date | 2022-01-06 |
| 00190707075972 - Maestro® Band Assemblies | 2025-12-19 .022 Maestro® LR6 Std Buccal Tube Epic / Cleat (E) |
| 00190707096755 - Reveal® Aligners | 2025-12-19 Reveal® Aligners |
| 00190707096762 - Reveal® Aligners | 2025-12-19 Reveal® Aligners |
| 00190707096779 - Reveal® Aligners | 2025-12-19 Reveal® Aligners |
| 00190707096786 - Reveal® Aligners | 2025-12-19 Reveal® Aligners |
| 00190707096793 - Reveal® Aligners | 2025-12-19 Reveal® Aligners |
| 00190707096809 - Reveal® Aligners | 2025-12-19 Reveal® Aligners |
| 00190707096816 - Reveal® Aligners | 2025-12-19 Reveal® Aligners |