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510(k) Data Aggregation

    K Number
    K060285
    Device Name
    BONEGEN - TR
    Date Cleared
    2006-03-16

    (41 days)

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

    BIO-LOK INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BoneGen-TR is indicated for use as follows: 1. By itself in bone regeneration procedures 2. Mixed with other bone graft materials (e.g. PRP, bone allograft, bone xenograft, demineralized freeze dried bone and/or a pure calcium sulfate based bone graft material) Oral Surgery: Post-extraction. Periodontics: Infra-osseous defects. Endodontics: Apioectomy, Root perforations, Open apices. Implantology: Dehiscences, fenestrations, sinus lifts.
    Device Description
    BoneGen - TR is manufactured by BioLok-International Inc. It is a composite of medical grade calcium sulfate hemihydrate and poly (1 lactic acid) in a 96:4 ratio. It is produced in pellet form: the size of pellets ranging from 425 - 850 microns. This composite undergoes slower degradation than calcium sulfate, overcoming the occasional disadvantage of rapid degradation of the pure medical grade calcium sulfate hemihydrate. It has a half-life of approximately 60 days and is usually completely degraded by 120 days. It can be used as a bone graft material on its own or it can be combined with a pure medical grade calcium sulfate hemihydrate bone graft material such as BoneGen. BoneGen - TR will be presented in 1.5 gram packages. Bony defects can be packed with BoneGen - TR pellets and can be closed with calcium suffate based, absorbable polymer based, collagen based or ePTFE based barriers. With time, BoneGen - TR pellets undergo degradation and is replaced by a calcium phosphate "trellis" that stimulate bone growth in the defect.
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    K Number
    K041136
    Device Name
    MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS
    Date Cleared
    2004-10-22

    (175 days)

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

    BIO-LOK INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
    Device Description
    Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment to cither the Silhouette™ (hex-top) or Silhouette ™ IC (internal connection) dental implants. Soft tissue attachment to the Laser-Lok surface treatment and the alignment of its micro-grooves inhibits epithelial down-growth on Silhouette Implants. The LaserLok treated collar on the Silhouette Dental Implant has been shown to attach and retain bone adjacent to the implant.
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    K Number
    K032454
    Device Name
    SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)
    Date Cleared
    2004-03-04

    (206 days)

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

    BIO-LOK INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
    Device Description
    The Silhouette™ (hex-top) and Silhouette ™ IC (internal connectivit) incorporate a self-tapping tapered implant design that provides lateral compression of the osteotomy site to meorporate a son-apping tapping aller and is flat in the lower supporting plane of the thread, passing compression forces to the bone and eliminating shear forces common to symmetrical the thead implants. The screw thead portion of the implants are surfaced roughened with Osseo-I ok™ per Bio-Coat, Inc. specifications. Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment.
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