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510(k) Data Aggregation

    K Number
    K141764
    Device Name
    TRISTAR BONE GRAFT FIXATION SYSTEM
    Manufacturer
    IMPLADENT, LTD.
    Date Cleared
    2014-12-18

    (170 days)

    Product Code
    JEY, DZL
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLADENT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.
    Device Description
    The TriStar Bone Graft Fixation System consists of titanium alloy self-drilling screws which are tapered and have a maximum diameter of 1.75mm with lengths of 3mm, 4mm, 5mm, 6mm, 8mm, 10mm, 12mm, 15mm, 18mm, 21mm, and 24mm. The screws are manufactured using a Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes a number of accessories used to fixate the screws and/or membranes or bone blocks to the host bone including a square headed morse tapered hand screw driver, screw driver handle, and latch type driver. The system includes titanium mesh in 40mm x 60mm or 18mm x 25mm sizes each having a thickness of 0.1mm. The screws and titanium mesh are designed to be removed from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single use only.
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    K Number
    K090794
    Device Name
    OSTEOTAPE
    Manufacturer
    IMPLADENT, LTD.
    Date Cleared
    2009-12-10

    (261 days)

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

    IMPLADENT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with Osteo Tape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®
    Device Description
    OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape) in various preformed shapes, is a resorbable bone grafting substitute comprised of highly purified Type I bovine collagen, used as a carrier derived from bovine Achilles tendon, combined with crystals of the product OsteoGen®, a synthetic bioactive resorbable graft of the non-ceramic hydroxylapatite category. The product is supplied in cubes and strip forms, sterile, and for single use only.
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    K Number
    K033098
    Device Name
    OSTEOGEN SBRG
    Manufacturer
    IMPLADENT, LTD.
    Date Cleared
    2004-04-27

    (211 days)

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

    IMPLADENT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As an aid in sinus augmentation (sinus lift) procedures. As an aid in the augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects. As an aid in the treatment of periapical and periodontal defects.
    Device Description
    Not Found
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    K Number
    K982925
    Device Name
    LAMINOSS DENTAL IMPLANT
    Manufacturer
    IMPLADENT, LTD.
    Date Cleared
    1999-05-18

    (271 days)

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

    IMPLADENT, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAMINOSS® Osteocompressive Implant System consists of a one-piece and twopiece immediately-loaded screw implants for the maxillary and mandibular arches to support fixed or removable prostheses.
    Device Description
    Not Found
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    K Number
    K933705
    Device Name
    LAMINOSS DENTAL IMPLANT
    Manufacturer
    IMPLADENT, LTD.
    Date Cleared
    1996-06-24

    (1060 days)

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

    IMPLADENT, LTD.

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