BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DenSureFit

    DI: 00863995000109 · Model: DSF212.00 · OTC DENTAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DenSureFit
    Primary DI
    00863995000109
    Version / Model
    DSF212.00
    Company Name
    OTC DENTAL CORPORATION
    Labeler DUNS
    080416887
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-23
    Public Version
    4
    Public Version Date
    2020-11-06
    Public Version Status
    Update
    Public Device Record Key
    9d894725-2763-41d0-81e4-8ccbce6758e3

    Device Description

    DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    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
    EBP Reliner, Denture, Over The Counter

    GMDN Terms

    Code Name
    31788 Denture reliner, soft, home-use

    Identifiers

    Type ID
    Primary 00863995000109