Cleared Traditional

K954128 - SNOREMASTER

K954128 is an FDA 510(k) clearance for SNOREMASTER, manufactured by D.D.S., Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K954128 · D.D.S., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
31d
Days
Class 2
Risk

K954128 is an FDA 510(k) clearance for the SNOREMASTER. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by D.D.S., Inc. (Half Moon Bay, US). The FDA issued a Cleared decision on October 2, 1995 after a review of 31 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 D.D.S., Inc. devices

FDA 510(k) Submission Details - K954128

510(k) Number K954128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date October 02, 1995
Days to Decision 31 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
96d faster than avg
Panel avg: 127d · This submission: 31d
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.