Cleared Traditional

K230225 - DynaFlex Clear Brackets & Buttons

K230225 is an FDA 510(k) clearance for DynaFlex Clear Brackets & Buttons, manufactured by Dyna Flex. The device is a Class 2 Dental device with product code NJM cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K230225 · Dyna Flex · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
129d
Days
Class 2
Risk

K230225 is an FDA 510(k) clearance for the DynaFlex Clear Brackets & Buttons. Classified as Bracket, Ceramic, Orthodontic (product code NJM), Class II - Special Controls.

Submitted by Dyna Flex (Lake Saint Louis, US). The FDA issued a Cleared decision on June 5, 2023 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dyna Flex devices

FDA 510(k) Submission Details - K230225

510(k) Number K230225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 127d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NJM Device Classification - Class 2, Special Controls

Product Code NJM Bracket, Ceramic, Orthodontic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NJM Bracket, Ceramic, Orthodontic

All 25
Devices cleared under the same product code (NJM) and FDA review panel - the closest regulatory comparables to K230225.
LightForce Orthodontic System
K232827 · Lightforce Orthodontics · Sep 2023
Cleo
K232011 · American Orthodontics · Jul 2023
A-Line Advanced
K231635 · Biocetec Co., Ltd. · Jun 2023
Ceramic Brackets Orthometric
K222847 · Orthometric - Industria E Comercio DE Produtos Medicos · May 2023
LightForce Orthodontic System
K222764 · Lightforce Orthodontics · Sep 2022
Vatech Clismile
K220689 · Rayence Co., Ltd. · May 2022