FDA.reportPublic FDA data

SECURE Denture Cushion Strips

Primary DI
00364031300097
Brand
SECURE Denture Cushion Strips
Company
FITTYDENT INTERNATIONAL GmbH
Model
F0315DUS
Device description
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.
Published
2023-10-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)Dental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00364031300097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00364031300097003640313000973640313000970364031300097

GMDN Terms#

Term, Definition table
TermDefinition
Carboxymethylcellulose sodium denture adhesiveAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300356295
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00364031300103SECURE Denture AdhesiveKL40 F0140DUS2023-10-02
00364031300165SECURE Cleansing TabletsF0232DUS2023-10-02
00364031300202SECURE Denture Adhesive SensitiveF0140MUS2023-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06943566100378Y-KelinANHUI GREENLAND BIOTECH CO.,LTDKOQ2022-12-06