Cleared Traditional

K032410 - SNORENTI

K032410 is an FDA 510(k) clearance for SNORENTI, manufactured by James P Boyd. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 574-day FDA review.

K032410 · James P Boyd · Dental device
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Feb 2005
Decision
574d
Days
Class 2
Risk

K032410 is an FDA 510(k) clearance for the SNORENTI. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by James P Boyd (Solana Beach, US). The FDA issued a Cleared decision on February 28, 2005 after a review of 574 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K032410

510(k) Number K032410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2003
Decision Date February 28, 2005
Days to Decision 574 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
446d slower than avg
Panel avg: 128d · This submission: 574d
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 K032410.
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
SNOREX
K971818 · Snorex (Nz) , Ltd. · Dec 1997
OSAP
K960673 · Snorefree, Inc. · May 1996
ADJUSTABLE PM POSITIONER
K955503 · Jonathan A. Parker, D.D.S. · Feb 1996
K032410 · SNORENTI
Download PDF James P Boyd