Cleared Traditional

SNORENTI (K032410) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all James P Boyd devices

Submission Details

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
Regulatory Context
Review time vs. panel average
447d slower than avg
Panel avg: 127d · This submission: 574d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.