Cleared Traditional

K193385 - TP Orthodontics Clear Aligner System (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193385 · Tp Orthodontics, Inc. · Dental device
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Nov 2020
Decision
342d
Days
Class 2
Risk

K193385 is an FDA 510(k) clearance for the TP Orthodontics Clear Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on November 12, 2020 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tp Orthodontics, Inc. devices

Submission Details

510(k) Number K193385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2019
Decision Date November 12, 2020
Days to Decision 342 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
215d slower than avg
Panel avg: 127d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - NXC Aligner, Sequential

All 142
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K193385.
SureSmile Aligner (ASSY500020)
K260722 · Dentsply Sirona, Inc. · Apr 2026
ZSmile System
K253282 · Dror Orthodesign , Ltd. · Feb 2026
Clear Aligner (SCF-3348)
K251454 · Beame Medical Technology (Shenzhen) Limited · Jan 2026
Primeprint Direct Aligner
K250739 · Dreve Dentamid GmbH · Nov 2025
Invisalign® Palatal Expander System
K252931 · Align Technology, Inc. · Oct 2025
Invisalign Specifix Attachment System
K252870 · Align Technology, Inc. · Oct 2025