Cleared Traditional

K123925 - MTM CLEAR ALIGNER IN-OFFICE

K123925 is an FDA 510(k) clearance for MTM CLEAR ALIGNER IN-OFFICE, manufactured by Dentsply International, Inc.. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K123925 · Dentsply International, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
May 2013
Decision
155d
Days
Class 2
Risk

K123925 is an FDA 510(k) clearance for the MTM CLEAR ALIGNER IN-OFFICE. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on May 24, 2013 after a review of 155 days - an extended review cycle.

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 Dentsply International, Inc. devices

FDA 510(k) Submission Details - K123925

510(k) Number K123925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2012
Decision Date May 24, 2013
Days to Decision 155 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
28d slower than avg
Panel avg: 127d · This submission: 155d
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 137
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K123925.
eCligner
K143499 · Eclear International Co., Ltd. · Oct 2015
CLEARPATH ALIGNER
K123514 · Qserve America, Inc. · Nov 2013
MTM(R) CLEAR ALIGNER
K132145 · Dentsply International, Inc. · Oct 2013
PONTIC PAINT
K130237 · Reliance Orthodontic Products, Inc. · Apr 2013
DYNAFLEX
K121396 · Dyna Flex · Aug 2012
CLEARCORRECT SYSTEM
K113618 · Clearcorrect, Inc. · Mar 2012