Cleared Traditional

K050592 - SOMNOMED MAS RXA

K050592 is an FDA 510(k) clearance for SOMNOMED MAS RXA, manufactured by Somnomed, Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K050592 · Somnomed, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
126d
Days
Class 2
Risk

K050592 is an FDA 510(k) clearance for the SOMNOMED MAS RXA. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Somnomed, Ltd. (Stillwater, US). The FDA issued a Cleared decision on July 12, 2005 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K050592

510(k) Number K050592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2005
Decision Date July 12, 2005
Days to Decision 126 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
2d faster than avg
Panel avg: 128d · This submission: 126d
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 216
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K050592.
SLEEP SPLINT
K060122 · Nakagawa Dental Clinic · May 2006
TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT
K060388 · Airway Management, Inc. · May 2006
SILENT PARTNER SERIES OSA APPLIANCES
K051014 · Dreamwrx Dental Laboratory · Aug 2005
NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
K041184 · Nti-Tss, Inc. · May 2005
ANTI-SNORING/SLEEP APNEA DEVICE
K042161 · Rj & VK Bird Pty , Ltd. · Oct 2004
PILLAR PALATAL IMPLANT SYSTEM
K040417 · Restore Medical, Inc. · Jul 2004
K050592 · SOMNOMED MAS RXA
Download PDF FDA Summary Somnomed, Ltd.