NJM

Bracket, Ceramic, Orthodontic

Product code

NJM

Device name

Bracket, Ceramic, Orthodontic

Device class

Class 2

21 CFR

21 CFR 872.5470

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

60 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-14.

1 summaries are archived here for direct download.