Definition: An Orthodontic Accessory Intended For Use During Orthodontic Treatment. It Is Used In Conjunction With Orthodontic Appliances Such As Braces And Helps Facilitate Minor Anterior Tooth Movement.
| Device Type ID | 1377 |
| Device Name | Orthodontic Vibratory Accessory |
| Physical State | The System Consists Of Four Components: The Activator, Mouthpiece, Charging Port, And Travel Shell. |
| Technical Method | The Device Functions By Providing Vibration To The Teeth. This Is Done For 20 Minutes A Day Per The Length Of The Entire Treatment. |
| Target Area | Patients With "separate Canine Retraction" And "en Masse" Retraction. |
| 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 | OYH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1377 |
| Device | Orthodontic Vibratory Accessory |
| Product Code | OYH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Orthodontic Plastic Bracket. |
| CFR Regulation Number | 872.5470 [🔎] |