Cleared Traditional

Ceramic Brackets Orthometric

K222847 · Orthometric - Industria E Comercio DE Produtos Medicos · Dental
May 2023
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K222847 is an FDA 510(k) clearance for the Ceramic Brackets Orthometric, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Orthometric - Industria E Comercio DE Produtos Medicos (Marilia, BR). The FDA issued a Cleared decision on May 4, 2023, 225 days after receiving the submission on September 21, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K222847 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2022
Decision Date May 04, 2023
Days to Decision 225 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NJM — Bracket, Ceramic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
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.