Cleared Abbreviated

K130067 - MRNA APPLIANCE

K130067 is an FDA 510(k) clearance for MRNA APPLIANCE, manufactured by Biomodeling Solutions, Lls. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 483-day FDA review.

K130067 · Biomodeling Solutions, Lls · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
483d
Days
Class 2
Risk

K130067 is an FDA 510(k) clearance for the MRNA APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Biomodeling Solutions, Lls (Beaverton, US). The FDA issued a Cleared decision on May 8, 2014 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Biomodeling Solutions, Lls devices

FDA 510(k) Submission Details - K130067

510(k) Number K130067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2013
Decision Date May 08, 2014
Days to Decision 483 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
356d slower than avg
Panel avg: 127d · This submission: 483d
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 86
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K130067.
REST EAZY Appliance
K172760 · Insert Molding Solutions, Inc. · Mar 2018
The Panthera Anti-Snoring X3 Device
K171576 · Panthera Dental, Inc. · Feb 2018
Snorer's Friend
K171529 · Scope Healthcare Technologies Pty, Ltd. · Jan 2018
MEDTRONIC XOMED, INC.
K122391 · Medtronic Xomed, Inc. · Jan 2013
PILLAR PALATAL IMPLANT SYSTEM
K110623 · Medtronic Xomed, Inc. · Feb 2012
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K070327 · Sybron Dental Specialties, Inc. · May 2007