BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BIO-C REPAIR

    DI: 07898078659847 · Model: BIO-C REPAIR 0.5 g · Angelus Industria de Produtos Odontologicos S A
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BIO-C REPAIR
    Primary DI
    07898078659847
    Version / Model
    BIO-C REPAIR 0.5 g
    Catalog Number
    3861
    Company Name
    Angelus Industria de Produtos Odontologicos S A
    Labeler DUNS
    906943303
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-05
    Public Version
    1
    Public Version Date
    2020-11-13
    Public Version Status
    New
    Public Device Record Key
    b37efc93-19ae-4785-885d-c1a29112509d

    Device Description

    Ready-to-use Bioceramic Reparative Material - BIO-C REPAIR 0.5 g

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    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
    KIF Resin, Root Canal Filling

    GMDN Terms

    Code Name
    36095 Endodontic filling/sealing material

    Identifiers

    Type ID
    Primary 07898078659847

    Customer Contacts

    Phone
    +554321013200
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180185 000