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.
60
Total
60
Cleared
111d
Avg days
1990
Since
Declining activity -
0 submissions in the last 2 years
vs 6 in the prior period
FDA 510(k) Cleared Bracket, Ceramic, Orthodontic Devices (Product Code NJM)
60 devices
Cleared
Jul 07, 2023
Cleo
American Orthodontics
Dental
1d
Cleared
May 06, 2022
Vatech Clismile
Rayence Co., Ltd.
Dental
58d
About Product Code NJM - Regulatory Context
510(k) Submission Activity
60 total 510(k) submissions under product code NJM since 1990, with 60 receiving FDA clearance (average review time: 111 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 6 in the prior period.
NJM devices are reviewed by the Dental panel. Browse all Dental devices →