NJM · Class II · 21 CFR 872.5470

FDA Product Code NJM: Bracket, Ceramic, Orthodontic

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.

Leading manufacturers include Rayence Co., Ltd. and American Orthodontics.

2
Total
2
Cleared
30d
Avg days
2022
Since

List of Bracket, Ceramic, Orthodontic devices cleared through 510(k)

2 devices
1–2 of 2

How to use this database

This page lists all FDA 510(k) submissions for Bracket, Ceramic, Orthodontic devices (product code NJM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Dental FDA review panel. Browse all Dental devices →