Young

Basic Information

• Brand Name: Young
• Primary DI: 00302732950685
• Version / Model: 295068
• Catalog Number: 13226940
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• Labeler DUNS: 006309355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-16
• Public Version: 2
• Public Version Date: 2022-11-10
• Public Version Status: Update
• Public Device Record Key: c01d312f-0e7e-437d-844d-2cb4c0091772

Device Description

Young Centrays, Anatomically Contoured Fluoride Trays, Medium, 50 White Upper Trays, 50 Blue Lower Arch Trays, 100ct - 13226940

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KMT	TRAY, FLUORIDE, DISPOSABLE	Dental	872.6870	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35701	Fluoride gel tray	A device typically made of styrofoam that is used to apply fluoride topically to the teeth. The device is designed to conform to the human mouth; a patient bites down on the device after it has been filled with a fluoride gel or solution for application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20302732950689	GS1	Case	12	In Commercial Distribution
Primary	00302732950685	GS1
Package	10302732950682	GS1	Bag	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]