Cleared Traditional

K143591 - Dorsal Appliance

K143591 is an FDA 510(k) clearance for Dorsal Appliance, manufactured by Gergens Orthodontic Lab. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K143591 · Gergens Orthodontic Lab · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
118d
Days
Class 2
Risk

K143591 is an FDA 510(k) clearance for the Dorsal Appliance. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Gergens Orthodontic Lab (Phoenix, US). The FDA issued a Cleared decision on April 15, 2015 after a review of 118 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 - K143591

510(k) Number K143591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date April 15, 2015
Days to Decision 118 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
10d faster than avg
Panel avg: 128d · This submission: 118d
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 Consultant

Backroads Consulting, Inc.
Karen E Warden,PhD

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.

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 K143591.
Respire Pink Series-Herbst-EF
K150572 · Respire Medical Holding · Aug 2015
The Moses Express appliance
K142651 · Allen J. Moses, Dds, Ltd. · Jul 2015
Somnowell Mandibular Advancement Appliance (MAA)
K150941 · Somnowell , Ltd. · May 2015
The Panthera Anti-Snoring Device
K143244 · Panthera Dental, Inc. · Dec 2014
THERASNORE
K140663 · Distar, LLC · Dec 2014
NDX DORSAL APPLIANCE
K133390 · Institute For Quality Resource Management · Oct 2014
K143591 · Dorsal Appliance
Download PDF FDA Summary Gergens Orthodontic L…