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OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor

by Mark Abramson, D.D.S., Inc.

510(k) K181571

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181571 Date19 Apr 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
PLC
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Oasys Oral/Nasal Airway System and Oasys Herbst with Dentitrac Patient Monitor is a sleep appliance designed to reduce snoring and mild to moderate obstructive sleep apnea. It functions by providing an oral and nasal airway system while incorporating a patient monitor to track usage in an adult population.

This device is classified as a Class II sleep appliance with patient monitoring and has received FDA 510(k) clearance. It is manufactured by Mark Abramson, D.D.S., Inc. and is identified under product code PLC.

Other devices from Mark Abramson, D.D.S., Inc.

Questions

AI-generated answers, 27 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 OASYS Oral/Nasal Airway System?

    This device is designed for use in an adult population to help reduce snoring and treat mild to moderate obstructive sleep apnea by providing an integrated oral and nasal airway system.

  • Does this device include a way to track patient usage?

    Yes, the system incorporates the Dentitrac Patient Monitor, which is specifically designed to track the usage of the appliance by the patient.

  • What is the regulatory status of this sleep appliance?

    The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor has received FDA 510(k) clearance under the classification of a Class II sleep appliance with patient monitoring, identified by product code PLC.