Cleared Traditional

K180346 - Byte Aligner System

K180346 is the FDA 510(k) clearance for Byte Aligner System by Straight Smile, LLC. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K180346 · Straight Smile, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
376d
Days
Class 2
Risk

K180346 is an FDA 510(k) clearance for the Byte Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Straight Smile, LLC (Pacific Palisades, US). The FDA issued a Cleared decision on February 19, 2019 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Straight Smile, LLC devices

Submission Details

510(k) Number K180346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2018
Decision Date February 19, 2019
Days to Decision 376 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
249d slower than avg
Panel avg: 127d · This submission: 376d
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

Coombs Medical Device Consulting, Inc.
Craig Coombs

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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K180346.
Argen Clear Aligner
K183229 · Argen Corporation · Jun 2019
Magic Clear Aligners
K190948 · Voodoo Manufacturing, Inc. · May 2019
Orthodontic Appliance
K181747 · Shandong Huge Dental Material Corporation · Apr 2019
Park Dental Research Aligners
K180648 · Park Dental Research Corporation · Jan 2019
Clear Image Aligners
K183643 · Specialty Appliance Works, Inc. · Jan 2019
3M Clarity Aligners
K183159 · 3M Company · Nov 2018