Cleared Abbreviated

K103704 - REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K103704 · Zephyr Sleep Technologies, Inc. · Dental device
Mar 2012
Decision
459d
Days
Class 2
Risk

K103704 is an FDA 510(k) clearance for the REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Zephyr Sleep Technologies, Inc. (Calgary; Alberta, CA). The FDA issued a Cleared decision on March 23, 2012 after a review of 459 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.

Submission Details

510(k) Number K103704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2010
Decision Date March 23, 2012
Days to Decision 459 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 158d · This submission: 459d
Pathway characteristics
Standards-based clearance path.

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 K103704.
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
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Myosa (S1H, S1, S2, S3, S1M, S2M)
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Park Dental Nylon MAD
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QuietLab Pro
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Hushd Avera
K252161 · Good Sleep CO Pte , Ltd. · Nov 2025
AIO Breathe
K252525 · Aiomega, LLC · Nov 2025