Cleared Traditional

RED, WHITE & BLUE (K040874) - FDA 510(k) Clearance

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

K040874 · Allesee Orthodontic Appliances · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
77d
Days
Class 2
Risk

K040874 is an FDA 510(k) clearance for the RED, WHITE & BLUE. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Allesee Orthodontic Appliances (Orange, US). The FDA issued a Cleared decision on June 18, 2004 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allesee Orthodontic Appliances devices

Submission Details

510(k) Number K040874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2004
Decision Date June 18, 2004
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 143
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K040874.
Smylio Aligners
K260788 · Smylio, Inc. · May 2026
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