Cleared Traditional

K061688 - ANTI-SNORING / SLEEP APNEA DEVICE

K061688 is an FDA 510(k) clearance for ANTI-SNORING / SLEEP APNEA DEVICE, manufactured by Tomed Dr. Toussaint GmbH. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K061688 · Tomed Dr. Toussaint GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
85d
Days
Class 2
Risk

K061688 is an FDA 510(k) clearance for the ANTI-SNORING / SLEEP APNEA DEVICE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Tomed Dr. Toussaint GmbH (Bensheim, DE). The FDA issued a Cleared decision on September 8, 2006 after a review of 85 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tomed Dr. Toussaint GmbH devices

FDA 510(k) Submission Details - K061688

510(k) Number K061688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2006
Decision Date September 08, 2006
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 86
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K061688.
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
TAP
K964516 · Nellcor Puritan Bennett, Inc. · Jan 1997