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Oravan OSA

by New Jersey Snoring Solutions

510(k) K121285

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121285 Date8 Mar 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Oravan OSA is a custom-fitted, two-piece intraoral appliance classified as an anti-snoring device. It is designed to treat mild to moderate obstructive sleep apnea by repositioning the jaw and tongue to maintain an open airway during sleep.

This device is supplied as a reusable, custom-molded oral appliance fabricated from acrylic, intended for use in dental settings. It requires professional fitting and adjustment by a healthcare provider. The Oravan OSA has received FDA 510(k) clearance under the Traditional pathway and is regulated under the classification code 872.5570.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Oravan OSA device, and how does it work?

    The Oravan OSA is designed to treat mild to moderate obstructive sleep apnea by repositioning the jaw and tongue to keep the airway open during sleep. It functions as a custom-fitted, two-piece intraoral appliance made of acrylic, which requires professional fitting and adjustment by a healthcare provider in a dental setting.

  • Is the Oravan OSA a single-use or reusable device, and what material is it made from?

    The Oravan OSA is a reusable device, not intended for single-use. It is fabricated from acrylic and is custom-molded to fit the patient’s mouth, ensuring durability and repeated use under professional supervision.

  • How is the Oravan OSA supplied, and does it require any special handling or storage?

    The Oravan OSA is supplied as a reusable, custom-fitted oral appliance intended for use in dental settings. Since it is custom-molded for each patient, it is not supplied pre-packaged like disposable devices. Storage should follow standard dental hygiene protocols to maintain cleanliness and prevent contamination, as it is not sterile out-of-box and requires professional fitting and maintenance.

  • What regulatory pathway was followed for FDA clearance of the Oravan OSA, and what classification does it fall under?

    The Oravan OSA received FDA 510(k) clearance under the Traditional pathway, classified as substantially equivalent to a predicate device. It is regulated under classification code 872.5570 and falls under the Dental medical specialty, specifically as an anti-snoring device.

  • Does the Oravan OSA come in multiple sizes or models, and how is the custom fit achieved?

    The Oravan OSA is a custom-fitted device, meaning it is not supplied in fixed sizes or models. Instead, each appliance is individually fabricated to match the patient’s dental structure, ensuring an optimal fit and therapeutic effect. This process requires professional dental expertise to mold and adjust the acrylic appliance.