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510(k) Data Aggregation

    K Number
    K033815
    Device Name
    BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    2004-01-15

    (37 days)

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

    GEISTLICH-PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filing of defects after root resection, apicocctomy, and cystectomy Filing of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Guided Tissue Regencration (GTR) and Guided Bone Regencration (GBR). Filing of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
    Device Description
    BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are natural non-antigenic, porous bone mineral matrixes. They arc produced by removal of all organic components from bovinc bone. Due to its natural structure, BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are physically and chemically comparable to the mineralized matrix of human bone. It is available as cortical granules and blocks.
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    K Number
    K014289
    Device Name
    ORTHOSS RESORBABLE BONE VOID FILLER
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    2002-03-28

    (90 days)

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

    GEISTLICH-PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ORTHOSS is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
    Device Description
    ORTHOSS™ Resorbable Bone Void Filler
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    K Number
    K970569
    Device Name
    BIO-BLOCKS
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    2000-08-14

    (1294 days)

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

    GEISTLICH-PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Augmentation of reconstructive treatment of the alveolar ridge Filling of defects after root resection, apicoeccomy and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge
    Device Description
    Not Found
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    K Number
    K974399
    Device Name
    BIO-OSS COLLAGEN
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    1998-09-16

    (299 days)

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

    GEISTLICH-PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicoectomy, and cystectomy rilling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). Filling of peri-implant defects in-conjunction with products-intended for Guided Bone Regeneration(GBR)
    Device Description
    Not Found
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    K Number
    K970321
    Device Name
    BIO-OSS ANORGANIC BOVINE BONE
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    1998-09-15

    (595 days)

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

    GEISTLICH-PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Augmentation or reconstructive treatment of alveolar ridge defects also of any indeasal defects Filling of periodontal defects Filling of defects after root resection, apicoectony, and cyscecomy, and cyscecomy of the also and of and and and and enhance preservarion of- the alveola Filling of defects after root teseccion, approactory, and of the alvestar ridge Elevacion of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Filling of periodontal defects in conjunector aren production (GBR). Guided Tissue Regeneration(GTR) and Guided Bone Regeneration(GBR). villag of peri-implant defects in conjunction with products intended for the before Bear archier/GRP) Guided Bone Regeneration (GBR)
    Device Description
    Anorganic Bovine Bone
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    K Number
    K972817
    Device Name
    RESOR-PIN RESORBABLE MEMBRANE PIN
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    1998-07-24

    (360 days)

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

    GEISTLICH-PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Resor-Pin is used in oral, dental and maxillofacial surgery and guided bone regeneration.
    Device Description
    Resor-Pin Resorbable Membrane Pin
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    K Number
    K960724
    Device Name
    BIO-GIDE RESORBABLE BILAYER MEMBRANE
    Manufacturer
    GEISTLICH-PHARMA
    Date Cleared
    1997-06-11

    (475 days)

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

    GEISTLICH-PHARMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and implants: augmentation around implants placed in immediate extract sockets; - augmentation around implants placed in delayed extraction sockets; . - . localized ridge augmentation for later implantation; - alveolar ridge reconstruction for prosthetic treatment - filling of bone defects after root resection, cystectomy, removal of retained teeth. Becayse of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)
    Device Description
    Not Found
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