FDA product code OYH: Orthodontic Vibratory Accessory
OYH is the FDA product code for orthodontic vibratory accessory. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under OYH, from 3 different applicants. The average 510(k) review took 212 days (median 254).
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.
Classification
| Field | Value |
|---|---|
| Device name | Orthodontic Vibratory Accessory |
| Device class | Class II |
| Regulation | 21 CFR 872.5470 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OYH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 135 |
| 2019 | 1 | 366 |
Compare with all 510(k) review times · Search every OYH clearance
Top OYH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthoaccel Technologies, Inc. | 3 | 2016-07-08 |
| Propel Orthodontics, LLC | 1 | 2019-11-01 |
| Orthoaccel Technology, Inc. | 1 | 2017-05-26 |
Most recent OYH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183018 | Propel Orthodontics, LLC | VPro5 | 2019-11-01 | 366 |
| K170093 | Orthoaccel Technology, Inc. | AcceleDent Optima | 2017-05-26 | 135 |
| K153048 | Orthoaccel Technologies, Inc. | AcceleDent Aura | 2016-07-08 | 263 |
| K130643 | Orthoaccel Technologies, Inc. | ACCELEDENT AURA | 2013-04-23 | 43 |
| K110661 | Orthoaccel Technologies, Inc. | ACCELEDENT | 2011-11-17 | 254 |
Recalls for OYH devices
openFDA lists no recalls for product code OYH.
Frequently asked questions
What is FDA product code OYH?
OYH is the FDA product code for orthodontic vibratory accessory. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel.
What device class is OYH?
Class II, regulation 21 CFR 872.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYH?
Across 5 cleared submissions the average was 212 days from receipt to decision (median 254).
Which companies have the most OYH clearances?
Orthoaccel Technologies, Inc. (3); Propel Orthodontics, LLC (1); Orthoaccel Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OYH
- Run a recall and safety report across every OYH manufacturer
- Watch product code OYH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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