Cleared Abbreviated

K260136 - Forza

K260136 is an FDA 510(k) clearance for Forza, manufactured by True Function Laboratory, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 263-day FDA review.

K260136 · True Function Laboratory, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
263d
Days
Class 2
Risk

K260136 is an FDA 510(k) clearance for the Forza. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by True Function Laboratory, Inc. (La Mesa, US). The FDA issued a Cleared decision on October 6, 2026 after a review of 263 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K260136

510(k) Number K260136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2026
Decision Date October 06, 2026
Days to Decision 263 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 128d · This submission: 263d
Pathway characteristics
Standards-based clearance path.

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 K260136.
PDR Airway Device
K262937 · Park Dental Research Corp. · Oct 2026
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
K262104 · Ram.Shaw Pte. , Ltd. · Aug 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
K260136 · Forza
Download PDF FDA Summary True Function Laborat…