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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
355d slower than avg
Panel avg: 128d · 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 214
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K130067.
MEDLEY GOLD
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K132506 · Michael D Williams Dds PA · May 2014
THE MOSES ELITE APPLIANCE
K132933 · Allen J. Moses, Dds, Ltd. · Apr 2014
LUCO HYBRID OSA APPLIANCE
K130797 · Luco Hybrid Osa Appliance, Inc. · Dec 2013
ASA ORAL APPLIANCES
K130504 · American Sleep Association · Oct 2013
K130067 · MRNA APPLIANCE
Download PDF FDA Summary Biomodeling Solutions…