Product code OYH

Device name

Orthodontic Vibratory Accessory

Medical specialty

Dental

Device class

2

Regulation number

872.5470

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset