Medical Device Manufacturer · US , Crofton , MD

Sleeping Well, LLC - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2009

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sleeping Well, LLC Dental ✕

6 devices

1-6 of 6

Cleared Jun 15, 2022

Cleared Jun 12, 2018

Cleared Jul 25, 2014

Cleared Dec 07, 2012

ZQUIET PRO-PLUS

Cleared Jun 22, 2010

ZQUIET MOUTHPIECE

Cleared Mar 10, 2009

ZQUIET MOUTHPIECE

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 19, 2026