Cleared Special

O2Vent W (K171316) - FDA 510(k) Clearance

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

K171316 · Oventus Manufacturing Pty, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
68d
Days
Class 2
Risk

K171316 is an FDA 510(k) clearance for the O2Vent W. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Oventus Manufacturing Pty, Ltd. (Indooroopilly, AU). The FDA issued a Cleared decision on July 11, 2017 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oventus Manufacturing Pty, Ltd. devices

Submission Details

510(k) Number K171316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2017
Decision Date July 11, 2017
Days to Decision 68 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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.

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All 210
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