BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Nexcomp A4

    DI: 08806387892298 · Model: 9229 · Meta Biomed Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Nexcomp A4
    Primary DI
    08806387892298
    Version / Model
    9229
    Company Name
    Meta Biomed Co., Ltd.
    Labeler DUNS
    688322841
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-19
    Public Version
    6
    Public Version Date
    2022-12-26
    Public Version Status
    Update
    Public Device Record Key
    d83aaacb-1af8-4679-8544-60213eb7f7a3
    Distribution End Date
    2018-11-15

    Device Description

    Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EBF Material, Tooth Shade, Resin

    GMDN Terms

    Code Name
    35870 Dental composite resin

    Identifiers

    Type ID
    Primary 08806387892298