DeviceClearance

Product code OYH— Dental

ACCELEDENT

Classification name
Orthodontic Vibratory Accessory
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OYH under 21 CFR 872.5470, via openFDA

Market context for product code OYH

FDA has cleared 5 devices under product code OYH between 2011 and 2019, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OYH

Recent clearances under product code OYH

Data sourced from openFDA. This site is unofficial and independent of the FDA.