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510(k) Data Aggregation

    K Number
    K101014
    Device Name
    BOND BONE
    Manufacturer
    M.I.S. IMPLANTS TECHNOLOGIES LTD.
    Date Cleared
    2010-10-21

    (192 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.S. IMPLANTS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.
    Device Description
    Bond Bone™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.
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    K Number
    K092555
    Device Name
    UNO NARROW IMPLANT
    Manufacturer
    M.I.S. IMPLANTS TECHNOLOGIES LTD.
    Date Cleared
    2010-01-05

    (138 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.S. IMPLANTS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNO Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by adjacent teeth and roots, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more Ø3.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
    Device Description
    The UNO Narrow Implant is a self tapping, root-form, two piece screw type dental implant, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The UNO Narrow Implant is provided in one diameter (3 mm) in the following lengths: 10mm, 11.5 mm, 13mm and 16mm. The implants are tapered with double thread (2mm pitch) for fast insertion. The implants surface is sand blasted and acid etched. The UNO Narrow Implant is a two piece device whereas the implant is to be used in combination with replaceable ball attachments anchor screws and healing caps. The Uno implants and healing caps are supplied sterile and are intended for single use only. The ball attachment anchor screws are supplied non-sterile since immediately after their placement the ball attachments are used for impression coping in plastic materials. The UNO Narrow Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-02- Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
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    K Number
    K080162
    Device Name
    UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
    Manufacturer
    M.I.S. IMPLANTS TECHNOLOGIES LTD.
    Date Cleared
    2008-04-22

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.S. IMPLANTS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices of partificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment one piose bend Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The If acting on a can factured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment one piooo oone matting are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.
    Device Description
    The Uno - One Piece Screw-Type Dental Implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type Dental Implant is made of one piece solid material comprised of the implant and abutment combination. The Uno implants are provided in two diameters. The Uno 3.0 mm dental implant is indicated for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The Uno 3.5 mm dental implant is indicated for placement in the premolar, cuspid and incisor regions. The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Implants are provided in several lengths of 10mm, 13mm and 16mm with diameters of 3.0mm, 3.5mm. The implants surface is sand blasted and acid etched to improve the osseointegration. The implants are tapered with double thread (2mm pitch) for fast insertion. The Uno implants are supplied sterile and are intended for single use only.
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    K Number
    K073461
    Device Name
    ORTHO ANCHOR SCREWS
    Manufacturer
    M.I.S. IMPLANTS TECHNOLOGIES LTD.
    Date Cleared
    2008-01-25

    (46 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.S. IMPLANTS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho Anchor Screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.
    Device Description
    The MIS Ortho Anchor Screws are self-tapping screws that are used as fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. The screw is manufactured as one piece screw made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The upper head of the screw has a cross-hole through which a wire can pass to fix the mandible and maxilla in the orthodontic procedure. The screw head is special designed to assist the use of orthodontic appliances. The Ortho Anchor Screws are provided in several lengths ranging between 5-10mm and diameters of 1.4mm, 1.6mm and 2mm. The screws are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are supplied sterile.
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    K Number
    K070022
    Device Name
    MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9
    Manufacturer
    M.I.S. IMPLANTS TECHNOLOGIES LTD.
    Date Cleared
    2007-04-20

    (107 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.S. IMPLANTS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
    Device Description
    The Mistral is a one stage, screw-type, internal octagon dental implant and is provided in the following range of dimensions: - Diameters: 3.75. 4.10 and 4.80 mm - Length: 8, 10, 11.50, 13 and 16 mm All implants are manufactured from medical grade 5 pure titanium, which meets requirements of standard ASTM F136. The required surface roughness and microgeometry of the implants is achieved by blasting sand particles and acid etching. Blasted surfaces archive more bone contact with the implant surface.
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    K Number
    K003191
    Device Name
    MIS IMPLANT SYSTEM DECIVE
    Manufacturer
    M.I.S. IMPLANTS TECHNOLOGIES LTD.
    Date Cleared
    2001-09-28

    (353 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.S. IMPLANTS TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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