| Primary Device ID | D841O624XXXX1 |
| NIH Device Record Key | fcae11c0-c449-49ad-a236-551af6bfc5e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLEARTEK2 |
| Version Model Number | 1 |
| Company DUNS | 006335558 |
| Company Name | Ortho Solutions, LC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | D841O624XXXX1 [Primary] |
| NJM | Bracket, Ceramic, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
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| D8418053R1 - Respire Blue+ Hard | 2026-03-05 |
| D8418054R1 - Respire Blue+ Hard/Soft | 2026-03-05 |
| D8418056R1 - Respire Blue+ EF | 2026-03-05 |
| D8418260R1 - Respire Pink AT Hard | 2026-03-05 |
| D8418261R1 - Respire Pink AT Hard/Soft | 2026-03-05 |
| D8418262R1 - Respire Pink AT Micro Hard | 2026-03-05 |
| D8418263R1 - Respire Pink AT Micro Hard/Soft | 2026-03-05 |