SECURE Cleansing Tablets

GUDID 00364031300165

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.

FITTYDENT INTERNATIONAL GmbH

Denture cleanser

• Primary Device ID: 00364031300165
• NIH Device Record Key: d9d50f92-f381-4d10-bb77-a4955e59aff2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SECURE Cleansing Tablets
• Version Model Number: F0232DUS
• Company DUNS: 300356295
• Company Name: FITTYDENT INTERNATIONAL GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00364031300165 [Primary]

FDA Product Code

• EFT: Cleanser, Denture, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-10
• Device Publish Date: 2023-10-02

Devices Manufactured by FITTYDENT INTERNATIONAL GmbH

• 00364031300097 - SECURE Denture Cushion Strips: 2023-10-10 An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in
• 00364031300103 - SECURE Denture Adhesive: 2023-10-10 An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in
• 00364031300165 - SECURE Cleansing Tablets: 2023-10-10An 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.
• 00364031300165 - SECURE Cleansing Tablets: 2023-10-10 An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), norm
• 00364031300202 - SECURE Denture Adhesive Sensitive: 2023-10-10 An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in