Cleared Traditional

K152159 - Oravan Herbst

K152159 is an FDA 510(k) clearance for Oravan Herbst, manufactured by Oravanosa, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K152159 · Oravanosa, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
87d
Days
Class 2
Risk

K152159 is an FDA 510(k) clearance for the Oravan Herbst. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Oravanosa, LLC (West Orange, US). The FDA issued a Cleared decision on October 29, 2015 after a review of 87 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.

FDA 510(k) Submission Details - K152159

510(k) Number K152159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2015
Decision Date October 29, 2015
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LRK Device, Anti-snoring

All 207
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