Cleared Traditional

DynaFlex Clear Brackets & Buttons

K230225 · Dyna Flex · Dental
Jun 2023
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K230225 is an FDA 510(k) clearance for the DynaFlex Clear Brackets & Buttons, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Dyna Flex (Lake Saint Louis, US). The FDA issued a Cleared decision on June 5, 2023, 129 days after receiving the submission on January 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K230225 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2023
Decision Date June 05, 2023
Days to Decision 129 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.