Cleared Abbreviated

K101709 - LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)

K101709 is an FDA 510(k) clearance for LAMBERGSLEEPWELL- SMARTRUSION (LSW-S), manufactured by Steven B. Lamberg, Dds. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 62-day FDA review.

K101709 · Steven B. Lamberg, Dds · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
62d
Days
Class 2
Risk

K101709 is an FDA 510(k) clearance for the LAMBERGSLEEPWELL- SMARTRUSION (LSW-S). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Steven B. Lamberg, Dds (Richmond, US). The FDA issued a Cleared decision on August 18, 2010 after a review of 62 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 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.

FDA 510(k) Submission Details - K101709

510(k) Number K101709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2010
Decision Date August 18, 2010
Days to Decision 62 days
Submission Type Abbreviated
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
66d faster than avg
Panel avg: 128d · This submission: 62d
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 213
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K101709.
DYNAFLEX
K103076 · Dyna Flex · Feb 2011
SLEEP APP
K100185 · Sleep Medicine Network, Inc. · Nov 2010
SNORE GUARD ADVANCE
K102118 · Ranir, LLC · Sep 2010
ZQUIET MOUTHPIECE
K093407 · Sleeping Well, LLC · Jun 2010
PASR/QUIETNITE
K093340 · Exact Supplies , Ltd. · Jun 2010
THE MOSES APPLIANCE
K093710 · Allen J. Moses, Dds, Ltd. · May 2010
K101709 · LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
Download PDF FDA Summary Steven B. Lamberg, Dds