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510(k) Data Aggregation

    K Number
    K113568
    Device Name
    MTA-FILLAPEX
    Manufacturer
    PAXMED INTERNATIONAL
    Date Cleared
    2012-08-21

    (263 days)

    Product Code
    KIF, CLA
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAXMED INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MTA Fillapex is a root canal sealer intended for the permanent sealing of root canals and may be used in combination with root canal obturation materials.
    Device Description
    MTA Fillapex is a mineral trioxide aggregate (MTA) and resin root canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA Fillapex is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation. The device is provided non-sterile.
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    K Number
    K022038
    Device Name
    SPI ONETIME DENTAL IMPLANT
    Manufacturer
    PAXMED INTERNATIONAL
    Date Cleared
    2002-07-15

    (21 days)

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

    PAXMED INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thommen SPI® ONETIME Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® ONETIME implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
    Device Description
    The two-stage HA-Ti Dental Implant acquired from HATI Dental AG by Thommen Medical AG has been modified to make it a one-piece one-stage transgingival implant and will be marketed as the SP1® ONETIME Dental Implant. Other components of the HA-Ti Dental Implant System have not been modified and are suitable for use with the modified implant, and will be sold under the SP10 Dental Implant System name. The Thommen SP1® ONETIME Dental Implant is a one-stage root form endosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transqingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in three lengths (8 mm, 11 mm, 14 mm, not including the 2.9 mm transgingiyal portion), with two diameters (4.2 mm, 5.0 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance,
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    K Number
    K010467
    Device Name
    UNIVERSAL DENTAL COPING (UDC)
    Manufacturer
    PAXMED INTERNATIONAL
    Date Cleared
    2001-09-28

    (224 days)

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

    PAXMED INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011223
    Device Name
    QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM
    Manufacturer
    PAXMED INTERNATIONAL
    Date Cleared
    2001-09-20

    (153 days)

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

    PAXMED INTERNATIONAL

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