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510(k) Data Aggregation

    K Number
    K212509
    Device Name
    OSSIX Breeze
    Manufacturer
    Date Cleared
    2022-07-18

    (343 days)

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

    Datum Dental Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for: - 1) Alveolar ridge augmentation and reconstruction, - 2) Alveolar ridge preservation consequent to tooth extractions, - 3) Over the window in sinus elevation procedures and for support of the Schneiderian membrane, - 4) In intra bony defects around teeth, - 5) Guided tissue regeneration procedures in periodontal defects.
    Device Description
    OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone regeneration. The membrane is manufactured from decellularized pericardia of pigs that are veterinary certified as fit for human consumption and is cross-linked using ribose. OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.
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    K Number
    K163714
    Device Name
    OSSIX BONE
    Manufacturer
    Date Cleared
    2017-07-18

    (200 days)

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

    Datum Dental Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OSSIX™ BONE is intended for the following uses: - Augmentation or reconstructive treatment of the alveolar ridge; - Filling of periodontal defects; - Filling of defects after root resection, apicoectomy and cystectomy; . - . Filling of extraction sockets to enhance preservation of the alveolar ridge; - Elevation of the maxillary sinus floor; - Filling of periodontal defects in coniunction 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
    OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. OSSIX™ BONE is designed as a 3-D highly porous scaffold with physiological pH. OSSIX™ BONE is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide; the shelf life of the device is 36 months. Due to its porous and fibered microstructure, the matrix readily absorbs fluids, adheres to the surrounding tissues, and provides a scaffold that guides bone growth and regeneration. After implantation, OSSIX™ BONE undergoes gradual resorption in the body. Preclinical studies demonstrated that 50% or greater implant material remains at the 6-month time point. OSSIX™ BONE is available in the following sizes: 0.125 CC (5x5x5 mm), 0.25 CC . (5x5x10 mm) and 0.5 CC (5x10x10 mm). OSSIX™ BONE is for prescription use only; it is intended to be implanted by trained dentists or oral surgeons in clinics during routine dental surgical procedures on adults with periodontal and bony defects of the maxillo-facial complex.
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    K Number
    K153549
    Device Name
    OSSIX VOLUMAX
    Manufacturer
    Date Cleared
    2016-08-04

    (237 days)

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

    Datum Dental Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: - Ridge augmentation for later implant insertions. - Simultaneous ridge augmentation and implant insertions. - Ridge augmentation around implants inserted in delayed extraction sites. - Ridge augmentation around implants inserted in immediate extraction sites. - Alveolar ridge preservation consequent to tooth (teeth) extraction(s). - Over the window in lateral window sinus elevation procedure. - In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved. - In intra bony defects around teeth. - For treatment of recession defects, together with coronally positioned flap. - In furcation defects in multi rooted teeth. - Localized gingival augmentation.
    Device Description
    OSSIX® VOLUMAX is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from veterinary certified pigs and is purified and cross-linked using ribose. OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration. Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm. Intended for use by dental surgeons.
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    K Number
    K160281
    Device Name
    OSSIX PLUS
    Manufacturer
    Date Cleared
    2016-08-04

    (184 days)

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

    Datum Dental Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OSSIX® PLUS is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: - Ridge augmentation for later implant insertions. - Simultaneous ridge augmentation and implant insertions. - Ridge augmentation around implants inserted in delayed extraction sites. - Ridge augmentation around implants inserted in immediate extraction sites. - Alveolar ridge preservation consequent to tooth (teeth) extraction(s). - Over the window in lateral window sinus elevation procedure. - In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved. - In intra bony defects around teeth. - For treatment of recession defects, together with coronally positioned flap. - In furcation defects in multi rooted teeth.
    Device Description
    OSSIX® PLUS is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from tendons of veterinary certified pigs and is purified and cross-linked using ribose. OSSIX® PLUS is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration. Available in sizes: 15x25 mm, 25x30 mm, and 30x40 mm. Intended for use by dental surgeons.
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