Young

Basic Information

• Brand Name: Young
• Primary DI: 00302732950647
• Version / Model: 295064
• Catalog Number: 13226936
• 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: 8d0e5940-d458-4d29-a130-85d3ab6ec22f

Device Description

Young Centwins, Anatomically Contoured Fluoride Trays - Hinged, Small, 50ct - 13226936

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	10302732950644	GS1	Bag	50	In Commercial Distribution
Primary	00302732950647	GS1
Package	20302732950641	GS1	Case	14	In Commercial Distribution

Customer Contacts

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