Cleared Traditional

K991449 - SNORE-AID PLUS

K991449 is an FDA 510(k) clearance for SNORE-AID PLUS, manufactured by Dental Imagineers, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K991449 · Dental Imagineers, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
87d
Days
Class 2
Risk

K991449 is an FDA 510(k) clearance for the SNORE-AID PLUS. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Dental Imagineers, LLC (Ocean, US). The FDA issued a Cleared decision on July 22, 1999 after a review of 87 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 Dental Imagineers, LLC devices

FDA 510(k) Submission Details - K991449

510(k) Number K991449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date July 22, 1999
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 112
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K991449.
ORAL SLEEP DISORDER AID
K991209 · Perl-Rad Sleep Disorder Lab · Sep 1999
DR. B'S MOUTHPIECE, MODEL 32129-10002
K991948 · Snore - Ezzer · Sep 1999
REPOSE BONE SCREW SYSTEM
K981677 · Influence, Inc. · Aug 1999
THE SNORE PEACE
K981923 · The Snore Peace Group · Aug 1998
SNORE-CURE ANTI-SNORING APPLIANCE
K980952 · Ortho-Tain, Inc. · Jun 1998
SNORE-EZZER
K974531 · Snore - Ezzer · Feb 1998