OYH — Orthodontic Vibratory Accessory Class II
FDA product code OYH covers "Orthodontic Vibratory Accessory", a Class II medical device regulated under 21 CFR 872.5470. Submissions are reviewed by the Dental panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OYH
- Device Class
- Class II
- Regulation Number
- 872.5470
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183018 | propel orthodontics | VPro5 | November 1, 2019 |
| K170093 | orthoaccel technology | AcceleDent Optima | May 26, 2017 |
| K153048 | orthoaccel technologies | AcceleDent Aura | July 8, 2016 |
| K130643 | orthoaccel technologies | ACCELEDENT AURA | April 23, 2013 |
| K110661 | orthoaccel technologies | ACCELEDENT | November 17, 2011 |