Cleared Traditional

Smylic Invisible Clear Aligners (K173784) - FDA 510(k) Clearance

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

K173784 · Smylio, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
253d
Days
Class 2
Risk

K173784 is an FDA 510(k) clearance for the Smylic Invisible Clear Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Smylio, Inc. (Fremont, US). The FDA issued a Cleared decision on August 23, 2018 after a review of 253 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.

View all Smylio, Inc. devices

Submission Details

510(k) Number K173784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2017
Decision Date August 23, 2018
Days to Decision 253 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
126d slower than avg
Panel avg: 127d · This submission: 253d
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 Consultant

Jcq Consulting
Bill Jacqmein

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K173784.
Invisalign System with Mandibular Advancement Feature
K181739 · Align Technology, Inc. · Oct 2018
Ormco Spark Aligner System
K182826 · Sybron Dental Specialties · Oct 2018
Orthocaps Twinaligner
K180241 · Ortho Caps GmbH · Sep 2018
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