Orthodontic Led Accessory
The Orthodontic LED Accessory (product code PLH) is a Class 2 dental device intended for use during orthodontic treatment in conjunction with brackets and wires or aligners to help facilitate minor anterior tooth movement, regulated under 872.5470. It requires 510(k) clearance and is eligible for third-party review. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PLH
- Device Class
- FDA class 2
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.