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.
| Device Type ID | 1382 |
| Device Name | Orthodontic Led Accessory |
| Physical State | The System Consists Of A Mouthpiece Containing LEDs, Software, And Battery, And A Separate Storage/charging Station. |
| Technical Method | The Device Functions By Applying Light Energy To The Tissue Surrouding Tooth Roots For A Photobiomodulation Effect. |
| Target Area | Alverolar Ridge Of Maxillary And Mandibular Arches Of Patients Currently Being Treated With Orthodontic Brackets/wires Or Aligners. |
| Regulation Description | Orthodontic Plastic Bracket. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1382 |
| Device | Orthodontic Led Accessory |
| Product Code | PLH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Orthodontic Plastic Bracket. |
| CFR Regulation Number | 872.5470 [🔎] |