Cleared Traditional

K090911 - IST SNORING APPLIANCE

K090911 is an FDA 510(k) clearance for IST SNORING APPLIANCE, manufactured by Dental Crafters. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K090911 · Dental Crafters · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
163d
Days
Class 2
Risk

K090911 is an FDA 510(k) clearance for the IST SNORING APPLIANCE. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Dental Crafters (Marshfeld, US). The FDA issued a Cleared decision on September 11, 2009 after a review of 163 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 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 - K090911

510(k) Number K090911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2009
Decision Date September 11, 2009
Days to Decision 163 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
35d slower than avg
Panel avg: 128d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQZ Device Classification - Class 2, Special Controls

Product Code LQZ Device, Jaw Repositioning
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 - LQZ Device, Jaw Repositioning

All 26
Devices cleared under the same product code (LQZ) and FDA review panel - the closest regulatory comparables to K090911.
MILLENIUM ANTI-SNORING DEVICE
K112627 · Millenium Dental Laboratory, Inc. · Jun 2012
SNORKEL
K112766 · Fellmar Company · Jun 2012
NARVAL CC
K113201 · Resmed Sas · Dec 2011
FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
K091035 · Bryan Keropian Dds · Jun 2009
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
K061228 · Bryan Keropian Dds · May 2006
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
K053065 · Bryan Keropian Dds · Jan 2006
K090911 · IST SNORING APPLIANCE
Download PDF FDA Summary Dental Crafters