Home / Device Classification / OYH

OYH — Orthodontic Vibratory Accessory Class II

FDA Device Classification

Classification Details

Product Code
OYH
Device Class
Class II
Regulation Number
872.5470
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K183018propel orthodonticsVPro5November 1, 2019
K170093orthoaccel technologyAcceleDent OptimaMay 26, 2017
K153048orthoaccel technologiesAcceleDent AuraJuly 8, 2016
K130643orthoaccel technologiesACCELEDENT AURAApril 23, 2013
K110661orthoaccel technologiesACCELEDENTNovember 17, 2011