Cleared Special

TRIOCLEAR System (K231884) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231884 · Modern Dental Laboratory (Dg) Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
66d
Days
Class 2
Risk

K231884 is an FDA 510(k) clearance for the TRIOCLEAR System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Modern Dental Laboratory (Dg) Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on September 1, 2023 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Modern Dental Laboratory (Dg) Co., Ltd. devices

Submission Details

510(k) Number K231884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2023
Decision Date September 01, 2023
Days to Decision 66 days
Submission Type Special
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
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Modern Dental Laboratory Co., Ltd.
Robin Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K231884.
Byte Aligner System
K230199 · Dentsply Sirona, Inc. · Oct 2023
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Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K232233 · Align Technology, Inc. · Sep 2023
Clear Aligner
K223517 · Wuxi EA Medical Instruments Technologies Limited. · Jun 2023
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
K231464 · 3M Company, Unitek Orthodontic Products · May 2023
STR8 Clear Aligner
K223141 · Str8 Oral Care · Apr 2023