BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3Delta Etemp

    DI: EDEL16110100 · Model: 1611010 · DeltaMed GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3Delta Etemp
    Primary DI
    EDEL16110100
    Version / Model
    1611010
    Catalog Number
    1611010
    Company Name
    DeltaMed GmbH
    Labeler DUNS
    344805101
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-15
    Public Version
    1
    Public Version Date
    2023-09-25
    Public Version Status
    New
    Public Device Record Key
    1a3f548a-85f4-4639-8d38-9bd1a6d837bb

    Device Description

    3Delta Etemp A1, 1000g

    Device Characteristics

    Single Use
    Yes
    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
    EBG Crown And Bridge, Temporary, Resin

    GMDN Terms

    Code Name
    45236 Temporary dental crown/bridge resin

    Identifiers

    Type ID
    Primary EDEL16110100

    Premarket Submissions

    Submission Number Supplement Number
    K200039 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    4 – 25 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    avoid direct sunlight