Cleared Traditional

K091035 - FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

K091035 is an FDA 510(k) clearance for FULL BREATH SLEEP APPLIANCE LOWER (FBSL), manufactured by Bryan Keropian Dds. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K091035 · Bryan Keropian Dds · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
75d
Days
Class 2
Risk

K091035 is an FDA 510(k) clearance for the FULL BREATH SLEEP APPLIANCE LOWER (FBSL). Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Bryan Keropian Dds (Tarzana, US). The FDA issued a Cleared decision on June 24, 2009 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K091035

510(k) Number K091035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2009
Decision Date June 24, 2009
Days to Decision 75 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
53d faster than avg
Panel avg: 128d · This submission: 75d
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 K091035.
SNORKEL
K112766 · Fellmar Company · Jun 2012
NARVAL CC
K113201 · Resmed Sas · Dec 2011
IST SNORING APPLIANCE
K090911 · Dental Crafters · Sep 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
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
K052862 · Bryan Keropian Dds · Dec 2005
K091035 · FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
Download PDF FDA Summary Bryan Keropian Dds