Cleared Traditional

Alien Aligners (K241187) - FDA 510(k) Clearance

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

K241187 · Alien Milling Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
88d
Days
Class 2
Risk

K241187 is an FDA 510(k) clearance for the Alien Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Alien Milling Technologies (Glendora, US). The FDA issued a Cleared decision on July 26, 2024 after a review of 88 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 Alien Milling Technologies devices

Submission Details

510(k) Number K241187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2024
Decision Date July 26, 2024
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 K241187.
Spark™ Clear Aligner System
K240501 · Ormco Corporation · Oct 2024
Illusion Aligner Pro: Illusion Aligner FLX
K233356 · Laxmi Dental Export Pvt., Ltd. · Aug 2024
Clear Moves Aligner
K241137 · Clear Moves Aligners · Aug 2024
Invisalign System
K241412 · Align Technology, Inc. · Jun 2024
DigiLine Direct Print Aligner System
K233935 · Park Dental Research Corporation · Apr 2024
Clear Moves Aligners
K240038 · Space Maintainers Laboratories (Sml) · Apr 2024