PLH · Orthodontic Led Accessory
Dental · 21 CFR 872.5470 · Class 2
Overview
| Product Code | PLH |
|---|---|
| Device Name | Orthodontic Led Accessory |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
Classification Rationale
Class II.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | Jun 9, 2023 | SESE |
| K143120 | OrthoPulse | Biolux Research , Ltd. | Jul 24, 2015 | SESE |
Top Applicants
- Biolux Technology GmbH — 1 clearance
- Biolux Research , Ltd. — 1 clearance
