Cleared Traditional

K061228 - FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR

K061228 is an FDA 510(k) clearance for FULL BREATH SLEEP APPLIANCE WITH POSTER..., 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 24-day FDA review.

K061228 · Bryan Keropian Dds · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
24d
Days
Class 2
Risk

K061228 is an FDA 510(k) clearance for the FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR. 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 May 26, 2006 after a review of 24 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 - K061228

510(k) Number K061228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2006
Decision Date May 26, 2006
Days to Decision 24 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
104d faster than avg
Panel avg: 128d · This submission: 24d
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 K061228.
NARVAL CC
K113201 · Resmed Sas · Dec 2011
IST SNORING APPLIANCE
K090911 · Dental Crafters · Sep 2009
FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
K091035 · Bryan Keropian Dds · Jun 2009
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
SNORENTI
K032410 · James P Boyd · Feb 2005
K061228 · FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
Download PDF FDA Summary Bryan Keropian Dds