Cleared Traditional

K173064 - ZAPnea Oral Appliance

K173064 is the FDA 510(k) clearance for ZAPnea Oral Appliance by B. Fareid, Dds, PC. It is a Class 2 Dental device (product code LRK) cleared through the Traditional 510(k) pathway after a 525-day FDA review.

K173064 · B. Fareid, Dds, PC · Dental device
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Mar 2019
Decision
525d
Days
Class 2
Risk

K173064 is an FDA 510(k) clearance for the ZAPnea Oral Appliance. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by B. Fareid, Dds, PC (Kingsburg, US). The FDA issued a Cleared decision on March 8, 2019 after a review of 525 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: High-complexity regulatory submission. Elevated predicate reliance profile. 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 B. Fareid, Dds, PC devices

Submission Details

510(k) Number K173064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date March 08, 2019
Days to Decision 525 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
398d slower than avg
Panel avg: 127d · This submission: 525d
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 85
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K173064.
TD Clip
K190051 · Zephyr Sleep Technologies, Inc. · Jun 2019
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K183443 · Somnomed, Inc. · May 2019
PureSleep (OTC use)
K190058 · Sleep Science Partners, Inc. · Apr 2019
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K182661 · Sketchpad Innovations, LLC · Feb 2019
TrueDorsal Devices
K180691 · True Function Laboratory, Inc. · Feb 2019
Zyppah Anti-Snoring Device
K182312 · Always More Marketing · Jan 2019