Cleared Traditional

K180691 - TrueDorsal Devices (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180691 · True Function Laboratory, Inc. · Dental device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 158d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K180691.
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
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Park Dental Nylon MAD
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QuietLab Pro
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Hushd Avera
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AIO Breathe
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