Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Vibratory Accessory
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.
- Companies listing it
- 33 makers
- Brands and models
- 3
- 510(k) clearances
- 50 in five years
- FDA name
- Orthodontic Vibratory Accessory
510(k) clearances per year, 1976–2026
Companies that list OYH
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Wright Engineered Plastics, Inc. | United States | Maker | HyperByte Mouthpiece · SureSmile VPro Mouthpiece | — | — |
| Kaertech Limited | Hong Kong SAR China | Maker | HypeByte; SureSmile VPRO | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 Nov 2019 | K183018 | VPro5 | Propel Orthodontics, LLC |
| 26 May 2017 | K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. |
| 8 Jul 2016 | K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. |
| 23 Apr 2013 | K130643 | ACCELEDENT AURA | Orthoaccel Technologies, Inc. |
| 17 Nov 2011 | K110661 | ACCELEDENT | Orthoaccel Technologies, Inc. |
Official records: FDA product classification for OYH · 21 CFR 872.5470.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026