OAT · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3640
Classification
FDA Product Code
OAT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3640
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.