Cleared Traditional

K971818 - SNOREX

K971818 is an FDA 510(k) clearance for SNOREX, manufactured by Snorex (Nz) , Ltd.. The device is a Class 2 Dental device with product code LQZ cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K971818 · Snorex (Nz) , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
216d
Days
Class 2
Risk

K971818 is an FDA 510(k) clearance for the SNOREX. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Snorex (Nz) , Ltd. (Springfield, US). The FDA issued a Cleared decision on December 18, 1997 after a review of 216 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 - K971818

510(k) Number K971818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1997
Decision Date December 18, 1997
Days to Decision 216 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
88d slower than avg
Panel avg: 128d · This submission: 216d
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 K971818.
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
OSAP
K960673 · Snorefree, Inc. · May 1996
ADJUSTABLE PM POSITIONER
K955503 · Jonathan A. Parker, D.D.S. · Feb 1996
PM POSITIONER
K953293 · Jonathan A. Parker, D.D.S. · Sep 1995
K971818 · SNOREX
Download PDF FDA Summary Snorex (Nz) , Ltd.