Pink EF Series,Splint

Basic Information

• Brand Name: Pink EF Series,Splint
• Primary DI: 06972677871846
• Version / Model: 184
• 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: 2022-08-26
• Public Version: 1
• Public Version Date: 2022-09-05
• Public Version Status: New
• Public Device Record Key: ebd98002-10d6-4c83-8aed-7a9f9ef4ad75

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
NSR	Prosthesis, Orthodontic	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
36311	Dental occlusal splint, preformed, reusable	A rigid or flexible prefabricated device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is typically made of standard, preformed materials that are not moulded, or intended to be moulded to a specific patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06972677871853	GS1
Primary	06972677871846	GS1