Cleared Traditional

ClearCorrect System (K220140) - FDA 510(k) Clearance

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

K220140 · Clearcorrect, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
260d
Days
Class 2
Risk

K220140 is an FDA 510(k) clearance for the ClearCorrect System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Clearcorrect, LLC (Round Rock, US). The FDA issued a Cleared decision on October 5, 2022 after a review of 260 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 Clearcorrect, LLC devices

Submission Details

510(k) Number K220140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2022
Decision Date October 05, 2022
Days to Decision 260 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
133d slower than avg
Panel avg: 127d · This submission: 260d
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 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K220140.
Tera Harz Clear
K223355 · Graphy, Inc. · Nov 2022
CREOKORREKT Aligners
K211427 · Creodent Prosthetics, Ltd. · Oct 2022
Nuvola
K222418 · Gruppo Europeo Ortodonzia Srl · Oct 2022
MyClearALIGN Dental Aligner System
K221475 · Key Dental Technologies, LLC · Aug 2022
Clear Aligner
K213026 · Shenzhen Meiming Dentistry Technology Co., Ltd. · Aug 2022
Arkligners
K220835 · Arklign Laboratories · Aug 2022