BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Harvest Dental HD Gum Strip

    K Number: K231389 · Decision Aug 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    5
    Review Days
    96

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Harvest Dental HD Gum Strip
    K Number
    K231389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Harvest Dental Products, LLC
    Date Received
    May 12, 2023
    Decision Date
    August 16, 2023
    Product Code
    EBI
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EBI Resin, Denture, Relining, Repairing, Rebasing

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EBI), ordered by most recent decision date.

    DB 4000 High Impact Denture Base

    FDA 510(k)
    FDA Class 2 ·Dental

    Denture Base

    FDA 510(k)
    FDA Class 2 ·Dental

    LuxCreo Flexible Partial Denture Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)

    FDA 510(k)
    FDA Class 2 ·Dental

    UltraPrint-Dental Denture UV

    FDA 510(k)
    FDA Class 2 ·Dental

    Freeprint® denture flex

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Harvest Dental Products, LLC

    K Number Device Name
    K222961 Harvest Conceal ZR Block Out
    K222489 Harvest Printable Resin
    K180578 Harvest Dental Polymer Blocks
    K132937 HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)