Orthodontic Vibratory Accessory
The Orthodontic Vibratory Accessory is a dental device intended for use during orthodontic treatment in conjunction with orthodontic appliances such as braces to help facilitate minor anterior tooth movement. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OYH, with regulation number 872.5470 under the Dental medical specialty.
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Basic Information
- Product Code
- OYH
- Device Class
- FDA class 2
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183018 | VPro5 | Nov 01, 2019 | Substantially Equivalent | Propel Orthodontics, LLC |
| K170093 | AcceleDent Optima | May 26, 2017 | Substantially Equivalent | Orthoaccel Technology, Inc. |
| K153048 | AcceleDent Aura | Jul 08, 2016 | Substantially Equivalent | Orthoaccel Technologies, Inc. |
| K130643 | ACCELEDENT AURA | Apr 23, 2013 | Substantially Equivalent | Orthoaccel Technologies, Inc. |
| K110661 | ACCELEDENT | Nov 17, 2011 | Substantially Equivalent | Orthoaccel Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.