Cleared Traditional

K140435 - MEDLEY GOLD

K140435 is an FDA 510(k) clearance for MEDLEY GOLD, manufactured by American Dental Sleep Medicine, Ip, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K140435 · American Dental Sleep Medicine, Ip, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
125d
Days
Class 2
Risk

K140435 is an FDA 510(k) clearance for the MEDLEY GOLD. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by American Dental Sleep Medicine, Ip, LLC (Wexford, US). The FDA issued a Cleared decision on June 26, 2014 after a review of 125 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.

FDA 510(k) Submission Details - K140435

510(k) Number K140435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2014
Decision Date June 26, 2014
Days to Decision 125 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
3d faster than avg
Panel avg: 128d · This submission: 125d
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.

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 K140435.
CRANE ACRYLIC HERBST APPLIANCE
K140429 · Crane Dental Laboratory, Inc. · Sep 2014
ZQUIET-SA
K140777 · Sleeping Well, LLC · Jul 2014
MICR02 OSA DEVICE
K133683 · Microdental, Inc. · Jul 2014
SOMNODENT FUSION, CLASSIC
K140278 · Somnomed, Inc. · Jun 2014
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
K132506 · Michael D Williams Dds PA · May 2014
MRNA APPLIANCE
K130067 · Biomodeling Solutions, Lls · May 2014
K140435 · MEDLEY GOLD
Download PDF FDA Summary American Dental Sleep…