Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008797926

FEI Number

3008797926

Entity Name

SLEEPING WELL, LLC

City/State/Country

Shelburne, VT, US

Establishment Address

138 Steeplebush Rd., Shelburne, VT 05482, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sleeping Well, LLC (Owner Number: 10034704)

Owner / Operator Contact Address

138 Steeplebush Rd., Shelburne, VT 05482, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140777

PMA Number

N/A

All Registered Proprietary Names

ZQuiet Pro-Plus ZQuiet Pro-Flex ZQuiet Clean ZQuiet ZQuiet Breathe ZQuiet Chin-UP ZQuiet Advance Anti-Snoring Mouthpiece ZQuiet-S.A.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2013-02-28
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2025-05-30
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2010-12-23
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2019-11-25
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2019-11-25
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2022-06-23
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2014-11-17

Official Correspondent

Daniel Webster

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sleeping Well, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008797926. Last updated year: 2026. Please use registration number 3008797926 when referencing this establishment in official correspondence.