Cleared Traditional

K160234 - OVENT

K160234 is an FDA 510(k) clearance for OVENT, manufactured by Oventus Manufacturing Pty, Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K160234 · Oventus Manufacturing Pty, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
45d
Days
Class 2
Risk

K160234 is an FDA 510(k) clearance for the OVENT. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Oventus Manufacturing Pty, Ltd. (Brisbane, AU). The FDA issued a Cleared decision on March 17, 2016 after a review of 45 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oventus Manufacturing Pty, Ltd. devices

FDA 510(k) Submission Details - K160234

510(k) Number K160234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2016
Decision Date March 17, 2016
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 127d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LRK Device Classification - Class 2, Special Controls

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

Regulatory Technology Services, LLC
MARK JOB

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.

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