SECURE Denture Adhesive

GUDID 00364031300103

An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.

FITTYDENT INTERNATIONAL GmbH

Carboxymethylcellulose sodium denture adhesive

• Primary Device ID: 00364031300103
• NIH Device Record Key: 8ca2568e-c98e-4bbc-b923-d116cfbe61a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SECURE Denture Adhesive
• Version Model Number: KL40 F0140DUS
• 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: false
• 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	00364031300103 [Primary]

FDA Product Code

• KOO: Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

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: 2023-10-10An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.
• 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: 2023-10-10 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