Cleared Special

K261134 - Dormiva Anti-Snoring Mouth Guard (FDA 510(k) Clearance)

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

K261134 · Koncept Innovators, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
37d
Days
Class 2
Risk

K261134 is an FDA 510(k) clearance for the Dormiva Anti-Snoring Mouth Guard. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Koncept Innovators, Inc. (Myrtle Beach, US). The FDA issued a Cleared decision on May 14, 2026 after a review of 37 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 Koncept Innovators, Inc. devices

Submission Details

510(k) Number K261134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2026
Decision Date May 14, 2026
Days to Decision 37 days
Submission Type Special
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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 Consultant

Newworld Regulatory Solutions, Inc.
Maureen Garner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LRK Device, Anti-snoring

All 210
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K261134.
ShaeferH
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