Cleared Traditional

K190687 - Twilite Appliance

K190687 is the FDA 510(k) clearance for Twilite Appliance by Stephen J Harkins, Dds, PC. It is a Class 2 Dental device (product code LRK) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K190687 · Stephen J Harkins, Dds, PC · Dental device
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Jul 2019
Decision
106d
Days
Class 2
Risk

K190687 is an FDA 510(k) clearance for the Twilite Appliance. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Stephen J Harkins, Dds, PC (Tucson, US). The FDA issued a Cleared decision on July 2, 2019 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Stephen J Harkins, Dds, PC devices

Submission Details

510(k) Number K190687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2019
Decision Date July 02, 2019
Days to Decision 106 days
Submission Type Traditional
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
21d faster than avg
Panel avg: 127d · This submission: 106d
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 Consultant

Stephen J Harkins, Dds, PC C/O Promedic, LLC
Paul Dryden

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 85
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K190687.
Sapphire Dorsal Comfort Fit
K181416 · Crane Dental Laboratory, Inc. · Sep 2019
O2Vent Optima
K190236 · Oventus Manufacturing Pty, Ltd. · Aug 2019
Silent Nite sl
K183270 · Prismatik Dentalcraft, Inc. · Jul 2019
TD Clip
K190051 · Zephyr Sleep Technologies, Inc. · Jun 2019
SomnoDent Avant
K183443 · Somnomed, Inc. · May 2019
PureSleep (OTC use)
K190058 · Sleep Science Partners, Inc. · Apr 2019