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TAP II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060388

by Airway Management Inc

Identifiers

510(k) Number
K060388 FDA 510(k)
FDA Product Code
LRK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.5570 FDA 510(k)
Regulation Number
872.5570 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TAP II is a dental oral appliance classified as an anti-snoring device, designed to manage mild to moderate obstructive sleep apnea (OSA). It functions by repositioning the lower jaw to maintain airway patency during sleep, thereby reducing snoring and improving breathing continuity. The device is intended for use in both home and sleep laboratory settings as a non-invasive alternative to traditional therapies.

The TAP II is supplied as a reusable device, consisting of upper and lower trays fitted to the patient’s teeth using impression material, connected via a hook-and-base mechanism. It is not sterile and requires customization for each patient via dental impressions. The device carries an FDA 510K clearance under the classification of Class II (Dental) and is regulated under the regulation number 872.5570. Multiple model references are associated with its registration.

Frequently asked questions

How is the TAP II oral appliance customized for individual patients and what materials are used in this process?

The TAP II is not pre-fabricated but requires customization for each patient using dental impressions. The device consists of upper and lower trays that are fitted to the patient’s teeth using impression material, which is applied during the customization process. This ensures a precise and comfortable fit tailored to the patient’s unique dental structure.

Is the TAP II device intended for single-use or can it be reused?

The TAP II is designed as a reusable device. It is not sterile and must be cleaned and maintained by the patient or under professional supervision to ensure proper hygiene and functionality over time.

What types of settings can the TAP II be used in, and how does this affect its application?

The TAP II is intended for use in both home and sleep laboratory settings. This versatility allows clinicians to prescribe it for patients to use at home while also enabling monitoring in controlled environments like sleep labs if needed.

What regulatory pathway was followed for the FDA clearance of the TAP II, and what does this mean for its use?

The TAP II received FDA clearance through a 510(k) submission, specifically under the classification of Class II (Dental) with a traditional clearance type. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for managing mild to moderate obstructive sleep apnea and snoring.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tap Ii Anti-snoring and Obstructive Sleep Apnea Oral Appliance With ..., Tap Ii Anti-snoring And Obstructive Sleep Apnea Oral Appliance With ..., Tap Ii Anti-snoring and Obstructive Sleep Apnea Oral Appliance With ..., Airway Management - Home - TAP Sleep Care

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Airway Management Inc
FDA Applicant
Airway Management, Inc.

Sources (1)

  • FDA 510(k) K060388 24 fields · synced Sep 19, 2026