TCS Fresh Concentrated Dental Appliance Cleaner

Basic Information

• Brand Name: TCS Fresh Concentrated Dental Appliance Cleaner
• Primary DI: D8054505SLV10
• Version / Model: 4505-SLV.1
• Catalog Number: 4505-SLV.1
• Company Name: THERMOPLASTIC COMFORT SYS
• Labeler DUNS: 808897776
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-30
• Public Version: 1
• Public Version Date: 2021-04-07
• Public Version Status: New
• Public Device Record Key: 7c60b6be-ef3c-4e2d-9df7-964c16d5eb68

Device Description

The TCS Fresh Concentrated Dental Appliance Cleaner is a concentrated cleaning powder for dissolution in water for the cleaning of dentures, partials, nightguards, sportsguards, snoreguards, aligners, and retainers.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFT	Cleanser, Denture, Over The Counter	Dental	872.3520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8054505SLV10	HIBCC

Customer Contacts

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