ZQuiet S.A.

Basic Information

• Brand Name: ZQuiet S.A.
• Primary DI: 00858522003289
• Version / Model: ZQSA-XD12M
• Company Name: SLEEPING WELL, LLC
• Labeler DUNS: 020904101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 195dd513-0ac0-49ed-987b-86c4cdba2aad

Device Description

Contains 3 of each of the following packaged assemblies: ZQuiet S.A. Dental Size A Single Unit - DI: 00858522003234 ZQuiet S.A. Dental Size B Single Unit - DI: 00858522003241 ZQuiet S.A. Dental Size C Single Unit - DI: 00858522003258 ZQuiet S.A. Dental Size D Single Unit - DI: 00858522003265

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47526	Mandible-repositioning sleep-disordered breathing orthosis	A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858522003289	GS1

Premarket Submissions

Submission Number	Supplement Number
K140777	000