Cleared Traditional

K133390 - NDX DORSAL APPLIANCE

K133390 is an FDA 510(k) clearance for NDX DORSAL APPLIANCE, manufactured by Institute For Quality Resource Management. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K133390 · Institute For Quality Resource Management · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
345d
Days
Class 2
Risk

K133390 is an FDA 510(k) clearance for the NDX DORSAL APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Institute For Quality Resource Management (St. Louis, US). The FDA issued a Cleared decision on October 16, 2014 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K133390

510(k) Number K133390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2013
Decision Date October 16, 2014
Days to Decision 345 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
217d slower than avg
Panel avg: 128d · This submission: 345d
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 K133390.
Dorsal Appliance
K143591 · Gergens Orthodontic Lab · Apr 2015
The Panthera Anti-Snoring Device
K143244 · Panthera Dental, Inc. · Dec 2014
THERASNORE
K140663 · Distar, LLC · Dec 2014
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
K133390 · NDX DORSAL APPLIANCE
Download PDF FDA Summary Institute For Quality…