Ceramic Brackets Orthometric— 510(k) K222847

Name: FDA 510(k) clearance K222847
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Substantially Equivalent

Orthometric - Industria E Comercio DE Produtos Medicos

FDA 510(k) clearance K222847 for Ceramic Brackets Orthometric, Substantially Equivalent on 2023-05-04. Applicant: Orthometric - Industria E Comercio DE Produtos Medicos. Device class: 2.

Clearance details

Applicant: Orthometric - Industria E Comercio DE Produtos Medicos
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2022-09-21
Decision date: 2023-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marilia, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code NJM

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K232827 — LightForce Orthodontic System2023-09-14
K232011 — Cleo2023-07-07
K231635 — A-Line Advanced2023-06-06
K230225 — DynaFlex Clear Brackets & Buttons2023-06-05
K222764 — LightForce Orthodontic System2022-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.