Cleared Traditional

K180691 - TrueDorsal Devices

K180691 is an FDA 510(k) clearance for TrueDorsal Devices, manufactured by True Function Laboratory, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K180691 · True Function Laboratory, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
332d
Days
Class 2
Risk

K180691 is an FDA 510(k) clearance for the TrueDorsal Devices. 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 February 11, 2019 after a review of 332 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all True Function Laboratory, Inc. devices

FDA 510(k) Submission Details - K180691

510(k) Number K180691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2018
Decision Date February 11, 2019
Days to Decision 332 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 127d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Azar & Associates
Nicolas Azar

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 167
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K180691.
PureSleep (OTC use)
K190058 · Sleep Science Partners, Inc. · Apr 2019
ZAPnea Oral Appliance
K173064 · B. Fareid, Dds, PC · Mar 2019
Kava and Kava with Herbst
K182661 · Sketchpad Innovations, LLC · Feb 2019
Zyppah Anti-Snoring Device
K182312 · Always More Marketing · Jan 2019
SLEEPAPP
K182202 · Comfort Acrylics, Inc. · Jan 2019
Elevo® Kit Snoring Intervention Device
K181107 · Zelegent, Inc. · Dec 2018