Cleared Traditional

K082556 - CLEARCORRECT

K082556 is an FDA 510(k) clearance for CLEARCORRECT, manufactured by Clearcorrect, 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.

K082556 · Clearcorrect, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
155d
Days
Class 2
Risk

K082556 is an FDA 510(k) clearance for the CLEARCORRECT. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Clearcorrect, Inc. (Claremont, US). The FDA issued a Cleared decision on February 6, 2009 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.

FDA 510(k) Submission Details - K082556

510(k) Number K082556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2008
Decision Date February 06, 2009
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
27d slower than avg
Panel avg: 128d · 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 144
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K082556.
CLEARCORRECT SYSTEM
K113618 · Clearcorrect, Inc. · Mar 2012
FS ALIGNER
K093821 · Allesee Orthodontic Appliances · Aug 2010
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
K073121 · Nubrace, Inc. · Feb 2009
INVISALIGN SYSTEM
K081960 · Align Technology · Dec 2008
COMPOSITE ALIGNER BUTTON
K080246 · Dentsply Interntional · Apr 2008
CLEAR IMAGE ALIGNER
K071970 · Specialty Appliance Works, Inc. · Sep 2007
K082556 · CLEARCORRECT
Download PDF FDA Summary Clearcorrect, Inc.