OYH · Orthodontic Vibratory Accessory
Dental · 21 CFR 872.5470 · Class 2
Overview
| Product Code | OYH |
|---|---|
| Device Name | Orthodontic Vibratory Accessory |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
Classification Rationale
Class II.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183018 | VPro5 | Propel Orthodontics, LLC | Nov 1, 2019 | SESE |
| K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | May 26, 2017 | SESE |
| K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | Jul 8, 2016 | SESE |
| K130643 | ACCELEDENT AURA | Orthoaccel Technologies, Inc. | Apr 23, 2013 | SESE |
| K110661 | ACCELEDENT | Orthoaccel Technologies, Inc. | Nov 17, 2011 | SESE |
Top Applicants
- Orthoaccel Technologies, Inc. — 3 clearances
- Propel Orthodontics, LLC — 1 clearance
- Orthoaccel Technology, Inc. — 1 clearance
