Anti-snoring, restoration

Basic Information

• Brand Name: Anti-snoring, restoration
• Primary DI: 06972677871600
• Version / Model: 160
• Company Name: Modern Dental Laboratory (DG) Co., Ltd.
• Labeler DUNS: 551746187
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-07-21
• Public Version: 2
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 3f138719-b070-4dbe-b72b-2e75e257337a

Device Characteristics

• Single Use: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRK	Device, Anti-Snoring	Dental	872.5570	2
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown		N

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
38614	Dental bridge, metal-ceramic	A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active
38593	Custom-made dental crown, metal/ceramic	A device made of a combination of metal and tooth-coloured ceramic, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06972677871617	GS1
Primary	06972677871600	GS1