Cleared Traditional

K040874 - RED, WHITE & BLUE

K040874 is an FDA 510(k) clearance for RED, manufactured by Allesee Orthodontic Appliances. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

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

FDA 510(k) Submission Details - K040874

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.

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.