Topex®

Basic Information

• Brand Name: Topex®
• Primary DI: D687AD320121
• Version / Model: AD32012
• Catalog Number: AD32012
• Company Name: Sultan Healthcare Inc
• Labeler DUNS: 056296981
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: 4e17cce9-9597-4f11-9298-be7083c11f42

Device Description

Topex® Dual Arch Tray Medium Bag of 50

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
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
Unit of Use	D687AD320120	HIBCC
Primary	D687AD320121	HIBCC