| Primary Device ID | 00850035489017 |
| NIH Device Record Key | c69fcb06-458c-4b3c-a7c5-57b5495212dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tweakz for Aligners |
| Version Model Number | ORN0002-01 |
| Company DUNS | 125732548 |
| Company Name | Orthonu 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 | false |
| Lot Batch | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850035489017 [Primary] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-20 |
| Device Publish Date | 2022-09-12 |
| 00850035489062 - Braces Treatment Starter Kitz | 2025-06-12 A Kit with 5 products including Tweakz for Braces, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips. |
| 00850035489079 - Aligner Treatment Starter Kitz | 2025-06-12 A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips. |
| 00850035489031 - Mouth-Aid | 2025-05-05 A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers. |
| 00850035489055 - Oral Relief Kitz | 2025-05-05 A Kit with 4 products including comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips. |
| 00850035489086 - Comfort Tape | 2025-05-05 A compound intended to be used as a protective cover for the general mucosa to treat irritated gingiva and sensitive teeth. |
| 00199284539792 - Comfort Tape™ | 2025-03-31 A compound intended to be used as a protective cover for the general mucosa to treat irritated gingiva and sensitive teeth. |
| 00199284797581 - Mouth-Aid | 2025-03-31 A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers. |
| 00850035489000 - Tweakz for Braces | 2022-09-27 |