Cleared Traditional

K991948 - DR. B'S MOUTHPIECE, MODEL 32129-10002

K991948 is an FDA 510(k) clearance for DR. B'S MOUTHPIECE, manufactured by Snore - Ezzer. 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.

K991948 · Snore - Ezzer · Dental device
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Sep 1999
Decision
85d
Days
Class 2
Risk

K991948 is an FDA 510(k) clearance for the DR. B'S MOUTHPIECE, MODEL 32129-10002. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Snore - Ezzer (Waukesha, US). The FDA issued a Cleared decision on September 2, 1999 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 Snore - Ezzer devices

FDA 510(k) Submission Details - K991948

510(k) Number K991948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1999
Decision Date September 02, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 112
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K991948.
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K981677 · Influence, Inc. · Aug 1999
SNORE-AID PLUS
K991449 · Dental Imagineers, LLC · Jul 1999
THE SNORE PEACE
K981923 · The Snore Peace Group · Aug 1998