NJM · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5470
Classification
FDA Product Code
NJM
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 ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.