Not Cleared Direct

MATRx plus (DEN170090) - FDA 510(k) Clearance

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

DEN170090 · Zephyr Sleep Technologies · Dental device
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Aug 2018
Decision
245d
Days
Class 2
Risk

DEN170090 is an FDA 510(k) submission (not cleared) for the MATRx plus. Classified as Closed Loop Auto Titration Device For Oral Appliances (product code QCJ), Class II - Special Controls.

Submitted by Zephyr Sleep Technologies (Calgary, CA). The FDA issued a Not Cleared (DENG) decision on August 23, 2018 after a review of 245 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5571 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Dental review framework.

View all Zephyr Sleep Technologies devices

Submission Details

510(k) Number DEN170090 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 21, 2017
Decision Date August 23, 2018
Days to Decision 245 days
Submission Type Direct
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 127d · This submission: 245d
Pathway characteristics

Device Classification

Product Code QCJ Closed Loop Auto Titration Device For Oral Appliances
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5571
Definition A Closed-loop Autotitration Device For Intraoral Appliances Uses A Feedback Control To Record Changes In The Patient’s Respiratory Status Related To Repositioning Of The Mandible During An Overnight Study. The Data Are Analyzed By A Healthcare Provider And Can Then Be Used To Prospectively Identify Patients With Mild To Moderate Obstructive Sleep Apnea Who May Be Suitable For Therapy With An Oral Appliance And To Recommend A Target Mandibular Position.
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.