BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Candid Refinement Impression Kit

    DI: 00850004223987 · Model: ITISK00001 · CANDID CARE CO.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Candid Refinement Impression Kit
    Primary DI
    00850004223987
    Version / Model
    ITISK00001
    Company Name
    CANDID CARE CO.
    Labeler DUNS
    108729170
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-31
    Public Version
    1
    Public Version Date
    2021-04-08
    Public Version Status
    New
    Public Device Record Key
    5cb0dcfe-5ac3-428c-8728-a98073136078

    Device Description

    Refinement Impression Kit (Medium Trays) Kett Putty Digital

    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
    Yes
    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
    ELW Material, Impression
    EHY Tray, Impression, Preformed
    EIG Retractor, All Types

    GMDN Terms

    Code Name
    35866 Silicone dental impression material

    Identifiers

    Type ID
    Primary 00850004223987

    Premarket Submissions

    Submission Number Supplement Number
    K082560 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    – 77 Degrees Fahrenheit