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ZQuiet Advance

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213088

by Sleeping Well, LLC

Identifiers

510(k) Number
K213088 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 ZQuiet Advance is an intraoral device for snoring and obstructive sleep apnea, classified under the regulation number 21 CFR 872.5570. It is designed to address snoring by targeting its source. The device is a type of anti-snoring device, falling under the device class 2 category.

The ZQuiet Advance is supplied by Sleeping Well, LLC, and has received FDA 510(k) clearance, indicated by the clearance number K213088. The device is intended for use in a dental setting, and its storage and use are subject to the manufacturer's instructions. The ZQuiet Advance is available in various configurations, but specific sizes are not provided in the available data.

Frequently asked questions

What is the ZQuiet Advance used for?

The ZQuiet Advance is used to address snoring and obstructive sleep apnea by targeting its source, and is intended for use in a dental setting.

Is the ZQuiet Advance sterile?

The provided data does not specify the sterility of the ZQuiet Advance, but its storage and use are subject to the manufacturer's instructions.

What configurations is the ZQuiet Advance available in?

The ZQuiet Advance is available in various configurations, but specific sizes are not provided in the available data.

What regulatory clearance has the ZQuiet Advance received?

The ZQuiet Advance has received FDA 510(k) clearance, indicated by the clearance number K213088, and is classified under the regulation number 21 CFR 872.5570.

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: ZQuiet Advance by Sleeping Well, LLC | FDA 510 (k) Summary, K213088 FDA 510(k) - ZQuiet Advance | Sleeping Well, LLC, Shop Stop Snoring Solutions Guaranteed to Work for You | ZQuiet

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sleeping Well, LLC

Sources (1)

  • FDA 510(k) K213088 24 fields · synced Oct 6, 2026