BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇱 Israel

    PERIOPATCH

    K Number: K110750 · Decision Apr 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    13
    Review Days
    42

    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
    PERIOPATCH
    K Number
    K110750
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mis Implants Technologies , Ltd.
    Date Received
    March 17, 2011
    Decision Date
    April 28, 2011
    Product Code
    OLR
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLR Oral Wound Dressing

    Similar 510(k) Clearances

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

    Curajel™ Oral Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    MuCover (proposed name) Oral Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    Dental Cone; Dental Sponge

    FDA 510(k)
    FDA Unclassified ·Unknown

    Silatrix Oral Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    Elemental Granulate

    FDA 510(k)
    FDA Unclassified ·Unknown

    HealiAid Dental Collagen Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Mis Implants Technologies , Ltd.

    K Number Device Name
    K182228 MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
    K180282 MIS Internal Hex Dental Implant System
    K173326 MIS CONNECT Conical Connection Abutment
    K172505 MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
    K163349 MIS V3 Conical Connection Dental Implant System­
    K112162 CONICAL CONNECTION IMPLANTS
    K101014 BOND BONE
    K092555 UNO NARROW IMPLANT
    K080162 UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
    K073461 ORTHO ANCHOR SCREWS
    Search all 13 clearances from Mis Implants Technologies , Ltd. →