Cleared Abbreviated

K162306 - SomnoDent ALPHA

K162306 is an FDA 510(k) clearance for SomnoDent ALPHA, manufactured by Somnomed, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 34-day FDA review.

K162306 · Somnomed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
34d
Days
Class 2
Risk

K162306 is an FDA 510(k) clearance for the SomnoDent ALPHA. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Somnomed, Inc. (Frisco, US). The FDA issued a Cleared decision on September 20, 2016 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Somnomed, Inc. devices

FDA 510(k) Submission Details - K162306

510(k) Number K162306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2016
Decision Date September 20, 2016
Days to Decision 34 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 128d · This submission: 34d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

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.