Cleared Abbreviated

K060795 - SOMNOFIT

K060795 is an FDA 510(k) clearance for SOMNOFIT, manufactured by Strategic Counsel Sarl. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 270-day FDA review.

K060795 · Strategic Counsel Sarl · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
270d
Days
Class 2
Risk

K060795 is an FDA 510(k) clearance for the SOMNOFIT. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Strategic Counsel Sarl (Leesburg, US). The FDA issued a Cleared decision on December 18, 2006 after a review of 270 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 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.

FDA 510(k) Submission Details - K060795

510(k) Number K060795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2006
Decision Date December 18, 2006
Days to Decision 270 days
Submission Type Abbreviated
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
142d slower than avg
Panel avg: 128d · This submission: 270d
Pathway characteristics
Standards-based clearance path.

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 214
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K060795.
ENDSNOR
K072731 · Dockstader Orthodontic Lab, Inc. · Jun 2008
SOMNOMED BFLEX
K073004 · Somnomed, Inc. · Jan 2008
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K070327 · Sybron Dental Specialties, Inc. · May 2007
LAIMAD
K062333 · Steven Lamberg, D.D.S · Dec 2006
TAP III ANTI-SNORING DEVICE
K062951 · Airway Management, Inc. · Dec 2006
ANTI-SNORING / SLEEP APNEA DEVICE
K061688 · Tomed Dr. Toussaint GmbH · Sep 2006
K060795 · SOMNOFIT
Download PDF FDA Summary Strategic Counsel Sarl