Device |
orthodontic vibratory accessory |
Regulation Description |
Orthodontic plastic bracket. |
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. |
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 Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | OYH |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
872.5470
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|