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NJM — Bracket, Ceramic, Orthodontic Class II

FDA Device Classification

Classification Details

Product Code
NJM
Device Class
Class II
Regulation Number
872.5470
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K222847orthometric - industria e comercio de produtos medicosCeramic Brackets OrthometricMay 4, 2023
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K220689rayence coVatech ClismileMay 6, 2022
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K200148lightforce orthodonticsLightForce Orthodontic System (LFO System)February 21, 2020
K182672gni coROSA BracketNovember 15, 2019
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K190608orthosun coMei Ceramic BracketNovember 4, 2019
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K182193biocetec coS-LineJanuary 22, 2019
K183542signature orthodonticsSignature Orthodontic SystemJanuary 2, 2019
K181271signature orthodonticsSignature Orthodontic SystemJune 13, 2018
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