Cleared Traditional

DNA Appliance (K234089) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 79
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