Cleared Traditional

K121396 - DYNAFLEX

K121396 is an FDA 510(k) clearance for DYNAFLEX, manufactured by Dyna Flex. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K121396 · Dyna Flex · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
97d
Days
Class 2
Risk

K121396 is an FDA 510(k) clearance for the DYNAFLEX. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Dyna Flex (St. Ann, US). The FDA issued a Cleared decision on August 14, 2012 after a review of 97 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 - K121396

510(k) Number K121396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2012
Decision Date August 14, 2012
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 128d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NXC Device Classification - Class 2, Special Controls

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
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 - NXC Aligner, Sequential

All 143
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K121396.
MTM(R) CLEAR ALIGNER
K132145 · Dentsply International, Inc. · Oct 2013
MTM CLEAR ALIGNER IN-OFFICE
K123925 · Dentsply International, Inc. · May 2013
PONTIC PAINT
K130237 · Reliance Orthodontic Products, Inc. · Apr 2013
CLEARCORRECT SYSTEM
K113618 · Clearcorrect, Inc. · Mar 2012
FS ALIGNER
K093821 · Allesee Orthodontic Appliances · Aug 2010
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
K073121 · Nubrace, Inc. · Feb 2009