Cleared Abbreviated

K140663 - THERASNORE

K140663 is an FDA 510(k) clearance for THERASNORE, manufactured by Distar, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 269-day FDA review.

K140663 · Distar, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
269d
Days
Class 2
Risk

K140663 is an FDA 510(k) clearance for the THERASNORE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Distar, LLC (Albuquerque, US). The FDA issued a Cleared decision on December 12, 2014 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 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 - K140663

510(k) Number K140663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date December 12, 2014
Days to Decision 269 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
141d slower than avg
Panel avg: 128d · This submission: 269d
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 K140663.
Somnowell Mandibular Advancement Appliance (MAA)
K150941 · Somnowell , Ltd. · May 2015
Dorsal Appliance
K143591 · Gergens Orthodontic Lab · Apr 2015
The Panthera Anti-Snoring Device
K143244 · Panthera Dental, Inc. · Dec 2014
NDX DORSAL APPLIANCE
K133390 · Institute For Quality Resource Management · Oct 2014
CRANE ACRYLIC HERBST APPLIANCE
K140429 · Crane Dental Laboratory, Inc. · Sep 2014
ZQUIET-SA
K140777 · Sleeping Well, LLC · Jul 2014
K140663 · THERASNORE
Download PDF FDA Summary Distar, LLC