Cleared Abbreviated

K062333 - LAIMAD

K062333 is an FDA 510(k) clearance for LAIMAD, manufactured by Steven Lamberg, D.D.S. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 126-day FDA review.

K062333 · Steven Lamberg, D.D.S · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
126d
Days
Class 2
Risk

K062333 is an FDA 510(k) clearance for the LAIMAD. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Steven Lamberg, D.D.S (Washington, US). The FDA issued a Cleared decision on December 14, 2006 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Steven Lamberg, D.D.S devices

FDA 510(k) Submission Details - K062333

510(k) Number K062333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2006
Decision Date December 14, 2006
Days to Decision 126 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Standards-based clearance path.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
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 - LRK Device, Anti-snoring

All 113
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K062333.
MEDTRONIC XOMED, INC.
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K070327 · Sybron Dental Specialties, Inc. · May 2007
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004
TONGUE STABILIZER DEVICE
K993381 · University of Otago · Dec 1999