OYH · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5470
Classification
FDA Product Code
OYH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.5470
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.