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510(k) Data Aggregation

    K Number
    K093122
    Device Name
    MBCP+
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2010-03-15

    (164 days)

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

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBCP+™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP+™ can be used with autogenous bone grafting materials. Typical uses include: - Periodontal/Infrabony defects - Ridge augmentation - Extraction sites (implant preparation/placement) - Sinus lifts - Cystic cavities
    Device Description
    MBCP+™ is a bone graft material used in dental applications. The MBCP+™ product consists of a biphasic ceramic (e.g hydroxyapatite and tricalcium phosphate beta). MBCP+™ dental product is a synthetic device, available in different sizes of granules. MBCP+™ product is available sterile for single use.
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    K Number
    K071121
    Device Name
    TRIBONE 80
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2007-09-11

    (144 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) 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. TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process. TRIBONE 80™ is to be used in association with adequate post-operative immobilization. TRIBONE 80™ is provided sterile for single patient use.
    Device Description
    TRIBONE 80™ is a bone graft substitute. TRIBONE 80™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 20% Hydroxyapatite (HA) and 80% beta-Tricalcium Phosphate (ß-TCP). TRIBONE 80™ is available in granules, sticks and blocks. TRIBONE 80™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). TRIBONE 80™ can also be mixed with autograft. TRIBONE 80™ is provided sterile for single patient use.
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    K Number
    K063527
    Device Name
    MBCP+
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2007-07-30

    (250 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBCP* ™ is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) 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. MBCP+TM is provided sterile for single patient use.
    Device Description
    MBCP+™ is a non structural bone graft substitute, which is resorbable and able to be replaced by newly-formed bone. The MBCP+™ is a ceramic constituted of two-phase of calcium phosphate 20 % hydroxyapatite and 80 % tricalcium phosphate beta. MBCP+™ is presented in a porous form. There are two types of porosity in MBCP+TM: The microporosity (pores smaller than 5μm) is constituted by all the spaces between the ceramic. The microporosity allows the biological fluids to circulate. The macroporosity (pores diameters bigger than 100µm) provides a porous scaffold upon which bone formation can occur at the expense of the ceramic.
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    K Number
    K060732
    Device Name
    MBCP GEL
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2006-06-02

    (74 days)

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

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBCP Gel™ is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP Gel™ can generally be used for bone filling in closed cavities. MBCP Gel™ can be used with autogenous bone grafting materials. Typical uses include but are not limited to: - . Periodontal/Infrabony defects - Ridge augmentation . - Extraction sites (implant preparation/placement) . - . Sinus lifts - Cystic cavities .
    Device Description
    MBCP Gel™ is a Resorbable Bone Graft Substitute that is rapidly replaced by newly-formed bone. This material is a non self setting gel providing mechanical resistance after healing and osseous rehabilitation. MBCP Gel™ is composed of biphasic Calcium Phosphate (60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (beta-TCP)) particles associated with an excipient with pharmaceutical grade quality (hydroxypropylmethylcellulose in an aqueous solution). The carrier acts as a spacer and a binder of the particles. MBCP Gel™ provides an environment for bone ingrowth. On time MBCP Gel™ is fully resorbable. MBCP Gel™ is provided sterile for single patient use in a syringe.
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    K Number
    K051774
    Device Name
    MBCP
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2006-01-20

    (203 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process. in addition, when used with appropriate opening osteotomy system devices, plates and screws, MBCP™ is intended to be used as a bone void filler in femoral or tibial osteotomies. MBCP™ is to be used in association with adequate post-operative immobilization.
    Device Description
    MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). MBCP™ is available in various shapes and sizes. MBCP™ granules are packaged in vials or syringes. MBCP™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). MBCP™ is provided sterile for single patient use.
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    K Number
    K051885
    Device Name
    MBCP
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2005-09-16

    (66 days)

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

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBCP™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP™ can be used with autogenous bone grafting materials. Typical uses include: - Periodontal/Infrabony defects . - Ridge augmentation . - Extraction sites (implant preparation/placement) . - Sinus lifts . - Cystic cavities .
    Device Description
    MBCP™ is a Resorbable Bone Graft Substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of Hydroxyapatite (HA) and beta-Tricalcium Phosphate (ß-TCP). MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone. MBCP™ is presented in a porous form required for the biological exchanges particularly for bone ingrowth and mineralization. The balance of a stable component (HA) and a more bioactive component (B-TCP) allied to the porosity involves the controlled process of ceramic resorption and bone substitution. When packed into the bony site, MBCP™ gradually resobs and is replaced with bone during the healing process.
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    K Number
    K043005
    Device Name
    MODIFICATION TO MBCP
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2005-05-03

    (183 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCP™ can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process. In addition, when used with appropriate opening osteotomy system devices, plates and screws. MBCP™ is intended to be used as a bone void filler in femoral or tibial osteotomies. MBCP™ is to be used in association with adequate post-operative immobilization.
    Device Description
    MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). MBCP™ is available in various shapes and sizes. MBCP™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). MBCP™ is provided sterile for single patient use.
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    K Number
    K032268
    Device Name
    MBCP
    Manufacturer
    BIOMATLANTE
    Date Cleared
    2003-12-11

    (141 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMATLANTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.
    Device Description
    MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate bone graft substitute consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (β-TCP). MBCP™ is available in granules or blocks. MBCP™ is provided sterile for single patient use. MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone. MBCP™ implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced by bone. The progressive resorption of the filler is intended to prevent premature resorption.
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