PLH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Orthodontic Led Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA definition
- Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
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| Record | Firm | Date |
|---|---|---|
| OrthoPulse 2.0E (OPi2E-100) (K230905) | Biolux Technology GmbH | 2023-06-09 |
| OrthoPulse (K143120) | Biolux Research , Ltd. | 2015-07-24 |
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