Cleared Traditional

K180346 - Byte Aligner System (FDA 510(k) Clearance)

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

K180346 · Straight Smile, LLC · Dental device
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.

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
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 158d · 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 Peers - NXC Aligner, Sequential

All 13
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K180346.
ZSmile System
K253282 · Dror Orthodesign , Ltd. · Feb 2026
Clear Aligner (SCF-3348)
K251454 · Beame Medical Technology (Shenzhen) Limited · Jan 2026
Primeprint Direct Aligner
K250739 · Dreve Dentamid GmbH · Nov 2025
Invisalign® Palatal Expander System
K252931 · Align Technology, Inc. · Oct 2025
Invisalign Specifix Attachment System
K252870 · Align Technology, Inc. · Oct 2025
Serafin®
K251758 · Tns Co., Ltd. · Sep 2025