OYH
5 FDA 510(k) clearances · Product code
254 daysmedian time to decision
366 days90th percentile
5clearances measured
FDA profile
- Official device name
- Orthodontic Vibratory Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VPro5 (K183018) | Propel Orthodontics, LLC | 2019-11-01 |
| AcceleDent Optima (K170093) | Orthoaccel Technology, Inc. | 2017-05-26 |
| AcceleDent Aura (K153048) | Orthoaccel Technologies, Inc. | 2016-07-08 |
| ACCELEDENT AURA (K130643) | Orthoaccel Technologies, Inc. | 2013-04-23 |
| ACCELEDENT (K110661) | Orthoaccel Technologies, Inc. | 2011-11-17 |
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Every clearance here is in the API, with alerts when new ones post.