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510(k) Data Aggregation

    K Number
    K130462
    Device Name
    PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
    Manufacturer
    PALTOP ADVANCED DENTAL SOLUTIONS LTD
    Date Cleared
    2013-08-27

    (186 days)

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

    PALTOP ADVANCED DENTAL SOLUTIONS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paltop 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 the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    Paltop Narrow Implants, as other implants available in the market, are essentially a substitute for a natural tooth. Paltop Narrow Implants, as other implants available in the market, are one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. As other implants available in the market, they are fabricated from titanium alloy, Titanium -6 Aluminum 4 Vanadium ELI alloy, according to ASTM F136-98, a biologically compatible material to vital tissue, and surface treated with sand blasting and acid etching. The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided. The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.
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    K Number
    K131451
    Device Name
    PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
    Manufacturer
    PALTOP ADVANCED DENTAL SOLUTIONS LTD
    Date Cleared
    2013-08-22

    (94 days)

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

    PALTOP ADVANCED DENTAL SOLUTIONS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paltop Dental Implant System 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. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    Paltop Dental Sterile Accessories are packaged is a standard, commonly used in the dental market, blister packaging made out of radiation resistant transparent polyethylene (PET) sealed with medical grade tyvek sheet. The accessories will be sterilized using gamma irradiation. Paltop Prosthetic Components include a variety of abutments, healing cups and impression coping components having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. The Paltop prosthetic components, as other available in the market dental prosthetics are dental components composed either of titanium (Ti6AL4V ELI) or peek. Paltop surgical instruments consist of a variety of instruments required for dentalsurgical and reconstructive procedures including primary and final drills, Key set and adapters. The Paltop surgical instruments, as other available in the market surgical instruments, are composed of stainless still or TI6AL4V ELI.
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    K Number
    K112795
    Device Name
    PALTOP DENTAL IMPLANT SYSTEM
    Manufacturer
    PALTOP ADVANCED DENTAL SOLUTIONS LTD
    Date Cleared
    2012-04-20

    (207 days)

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

    PALTOP ADVANCED DENTAL SOLUTIONS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paltop Dental Implant System 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. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    Paltop Advanced Dental Solutions Implant System consists of a one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. Each implant is accompanied by standard cover screws, healing caps, abutment system superstructures and surgical instruments. The Paltop dental implant system is composed of the following implant families: Paltop Advanced screw type implants and Paltop Dynamic screw type implants. Each implant is accompanied by a standard cover screw. Paltop dental implants are made of Ti 6Al 4V ELI, and shall meet the requirements of ASTM F136. "Paltop Advanced" are screw type implants, with double leaded "V" shape progressive external thread profile along the implants body, and fine threads at its neck. It has an internal hex. connection and a domed apex. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. "Paltop Dynamic" are screw type implants, with 3 different thread geometries: double leaded "V" shape progressive external thread profile at the apical portion, modified reverse buttress along its body and fine thread at the neck. It has an internal hex. connection. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. A collar portion is located at a coronal end of the dental implant. A central bore extends through the collar portion and into the implant body portion. The central bore includes a threaded section for receiving a threaded portion of a screw and post receiving section. The post receiving section consists of hex geometry for antirotational features and a conical section (above the hex) which interfaces with the abutment. The designed threads provides secure primary fixation. This design is responsible for transferring the load from the abutment/prosthesis to the implant body.
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