Cleared Special

K262104 - Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)

K262104 is an FDA 510(k) clearance for Anti Snoring Mouthpiece (L09-BB, manufactured by Ram.Shaw Pte. , Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 65-day FDA review.

K262104 · Ram.Shaw Pte. , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
65d
Days
Class 2
Risk

K262104 is an FDA 510(k) clearance for the Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Ram.Shaw Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 27, 2026 after a review of 65 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.

FDA 510(k) Submission Details - K262104

510(k) Number K262104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2026
Decision Date August 27, 2026
Days to Decision 65 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
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Ram.Shaw Pte. , Ltd.
Emma Chen

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 216
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K262104.
PDR Airway Device
K262937 · Park Dental Research Corp. · Oct 2026
Forza
K260136 · True Function Laboratory, Inc. · Oct 2026
SnØreNegatØr
K261912 · DnB Innovations, LLC · Jul 2026
Virtus
K261366 · Somnomed, Inc. · Jun 2026
Snorbliss® Anti-Snoring Device
K261251 · Endeavor Commerce, LLC · Jun 2026
Dormiva Anti-Snoring Mouth Guard
K261134 · Koncept Innovators, Inc. · May 2026
K262104 · Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
Download PDF FDA Summary Ram.Shaw Pte. , Ltd.