Cleared Special

K130558 - SOMNODENT HERBST (FDA 510(k) Clearance)

Also includes:
CLASSIC, FLEX

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130558 · Somnomed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
74d
Days
Class 2
Risk

K130558 is an FDA 510(k) clearance for the SOMNODENT HERBST. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Somnomed, Inc. (Frisco, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 74 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Somnomed, Inc. devices

Submission Details

510(k) Number K130558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date May 17, 2013
Days to Decision 74 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 209
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