SECURE Denture Adhesive Sensitive

GUDID 00364031300202

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 ID00364031300202
NIH Device Record Key5474fdc1-32c6-4156-9470-d1b600f32326
Commercial Distribution StatusIn Commercial Distribution
Brand NameSECURE Denture Adhesive Sensitive
Version Model NumberF0140MUS
Company DUNS300356295
Company NameFITTYDENT INTERNATIONAL GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100364031300202 [Primary]

FDA Product Code

KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

Devices Manufactured by FITTYDENT INTERNATIONAL GmbH

00364031300097 - SECURE Denture Cushion Strips2023-10-10 An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in
00364031300103 - SECURE Denture Adhesive2023-10-10 An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in
00364031300165 - SECURE Cleansing Tablets2023-10-10 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 Sensitive2023-10-10An 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.
00364031300202 - SECURE Denture Adhesive Sensitive2023-10-10 An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in

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