Cleared Traditional

K171674 - Angel Align System

K171674 is the FDA 510(k) clearance for Angel Align System by Smile Development Corp. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K171674 · Smile Development Corp · Dental device
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Jan 2018
Decision
227d
Days
Class 2
Risk

K171674 is an FDA 510(k) clearance for the Angel Align System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Smile Development Corp (Highland, US). The FDA issued a Cleared decision on January 19, 2018 after a review of 227 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.

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Submission Details

510(k) Number K171674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2017
Decision Date January 19, 2018
Days to Decision 227 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
100d slower than avg
Panel avg: 127d · This submission: 227d
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 124
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K171674.
Smart Moves Complete
K172765 · Great Lakes Orthodontics, Ltd. · Jun 2018
Custom Clear Aligner System
K173785 · Derby Dental Laboratory · Mar 2018
Blue Sky Bio Aligner
K180107 · Blue Sky Bio, LLC · Feb 2018
Sureclear aligners
K171860 · Emergo Global Consulting, LLC · Jan 2018
MTM Clear Aligner
K163155 · Dentsply Sirona · Feb 2017