Cleared Traditional

Cleo

K232011 · American Orthodontics · Dental

Jul 2023

Decision

Days

Class 2

Risk

About This 510(k) Submission

K232011 is an FDA 510(k) clearance for the Cleo, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on July 7, 2023, 1 days after receiving the submission on July 6, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K232011 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2023
Decision Date	July 07, 2023
Days to Decision	1 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.