Cleared Traditional

K140278 - SOMNODENT FUSION, CLASSIC

Also marketed or referenced as:
SOMNODENT FUSION, FLEX

K140278 is an FDA 510(k) clearance for SOMNODENT FUSION, manufactured by Somnomed, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K140278 · Somnomed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
137d
Days
Class 2
Risk

K140278 is an FDA 510(k) clearance for the SOMNODENT FUSION, CLASSIC. 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 June 20, 2014 after a review of 137 days - within the typical 510(k) review window.

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 Somnomed, Inc. devices

FDA 510(k) Submission Details - K140278

510(k) Number K140278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date June 20, 2014
Days to Decision 137 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
9d slower than avg
Panel avg: 128d · This submission: 137d
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.

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