Cleared Traditional

K234089 - DNA Appliance

K234089 is an FDA 510(k) clearance for DNA Appliance, manufactured by Vivos Therapeutics. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K234089 · Vivos Therapeutics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
269d
Days
Class 2
Risk

K234089 is an FDA 510(k) clearance for the DNA Appliance. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Vivos Therapeutics (Murray, US). The FDA issued a Cleared decision on September 16, 2024 after a review of 269 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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 Vivos Therapeutics devices

FDA 510(k) Submission Details - K234089

510(k) Number K234089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date September 16, 2024
Days to Decision 269 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
142d slower than avg
Panel avg: 127d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 - LRK Device, Anti-snoring

All 85
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K234089.
Oniris
K250353 · Oniris · Sep 2025
SleepRight Snore Aid
K250122 · Splintek, Inc. · May 2025
Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
K250482 · Fissiontech, LLC · May 2025
Hushd Pro Avera
K232025 · Good Sleep CO Pte , Ltd. · May 2024
EMA 3D
K232735 · Ema Sleep Incorporated · May 2024
Difiney Anti Snoring Device
K233850 · Fissiontech, LLC · Apr 2024