Tissue and Bone Regeneration With Ease

FULL INSTRUCTIONS FOR USE

TO ORDER ANY OSSIX PRODUCT, PLEASE CONTACT CUSTOMER SERVICE AT 1-866-273-7846.

The OSSIX product portfolio offers a variety of guided tissue and bone regeneration solutions that address a wide range of procedural needs. The OSSIX product line is manufactured by Datum Dental Ltd. and is available directly through OraPharma.

OSSIX products* are developed using a proprietary cross-linking process called GLYMATRIX technology. This unique, natural biochemical process promotes active integration with the host tissue for excellent biocompatibility and bio-durability, so you can confidently perform regenerative procedures with ease.1,2

*Excludes OSSIX GRAFT.

INDICATION FOR OSSIX Bone | BONE GRAFTING MATERIALOSSIX Bone is a sterile, biocompatible bone grafting material aimed to fill, augment, or reconstruct periodontal and bony defects of the maxillo-facial complex.

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INDICATION FOR OSSIX® PLUS AND OSSIX VOLUMAX | RESORBABLE COLLAGEN MAMBRANESOSSIX PLUS and OSSIX VOLUMAX biodegradable collagen membranes are intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

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INDICATION FOR OSSIX GRAFT | PARTICULATE AUTOGRAFTOSSIX GRAFT Particulate Allograft products consist of cortical bone matrix and may be used in a variety of reconstructive, periodontal, and oral maxillofacial procedures. OSSIX GRAFT contains Human Cellular and Tissue Based Product (HCT/P).

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OSSIX Products:

Image of the OSSIX Bone product - a shapeable, ossifying scaffold for the growth of natural bone.
OSSIX Bone: A shapeable, ossifying scaffold for the growth of natural bone in periodontal and implant procedures. Its unique design makes it easy to use, has no particle migration and actively integrates with host tissue.3
Image of the OSSIX VOLUMAX product - a biodegradable collagen membrane used in guided bone and tissue regeneration procedures to restore lost volume.
OSSIX VOLUMAX: A biodegradable collagen membrane for restoring lost volume in guided bone and tissue regeneration procedures. Its proprietary layering technology provides greater thickness for durability and porosity for healing.
Image of the OSSIX PLUS product - a durable, biodegradable collagen membrane, designed for optimal handling and placement.
OSSIX PLUS: A durable, biodegradable collagen membrane designed for optimal handling and ease of placement. It provides prolonged barrier function in a wide range of guided bone and tissue regeneration procedures.4
Image of the OSSIX GRAFT product that can be used in a variety of periodontal and oral maxillofacial procedures.
OSSIX Graft: A particulate allograft that consists of cortical bone matrix and may be used in a variety of reconstructive, periodontal and oral maxillofacial procedures.
REFERENCES: 1. Zubery Y, Goldlust A, Alves A, Nir E. Ossification of a novel cross-linked porcine collagen barrier in guided bone regeneration in dogs. J Periodontol. 2007;78(1):112-121. 2. Zubery Y, Nir E, Goldlust A. Ossification of a collagen membrane cross-linked by sugar: a human case series. J Periodontol. 2008;79(6):1101-1107. 3. Zubery Y, Goldlust A, Bayer T, Woods S, Jackson N, Soskolne WA. Alveolar ridge restoration using a new sugar cross-linked collagen-hydroxyapatite matrix in canine L-shape defects. Datum Dental. Poster presented at: Academy of Osseointegration 2017 Annual Meeting; March 15-18, 2017; Orlando, FL. http://www.ossixdental.com/images/Alveolar_Ridge_Restoration_AAP_MKT0040_Ver_01_reading_flow.pdf. Accessed August 12, 2018. 4. Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011;31(5):457-469.

INDICATION FOR OSSIX BoneOSSIX Bone is a sterile, biocompatible bone grafting material aimed to fill, augment, or reconstruct periodontal and bony defects of the maxillo-facial complex.

    IMPORTANT SAFETY INFORMATION FOR OSSIX Bone | BONE GRAFTING MATERIAL
  • OSSIX Bone must not be used in:
    • Patients with known collagen hypersensitivity.
    • Patients with a sensitivity to porcine-derived materials.
    • Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
    • Patients with acute or chronic infection (osteomyelitis) at the surgical site.
    • Patients with vascular impairment at the implant site.
    • Patients with uncontrolled periodontal disease.
    • Patients that have received or are currently receiving treatment with bisphosphonates.
    • OSSIX Bone should not be used in the presence of infected wounds at the site of implantation.
  • OSSIX Bone is intended for a single use only. Do not re-sterilize or reuse.
  • As OSSIX Bone contains collagen, allergic reactions (e.g. erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

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INDICATION FOR OSSIX® PLUS AND OSSIX® VOLUMAX | RESORBABLE COLLAGEN MEMBRANESOSSIX PLUS and OSSIX VOLUMAX biodegradable collagen membranes are intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

    IMPORTANT SAFETY INFORMATION FOR OSSIX® PLUS AND OSSIX® VOLUMAX
  • OSSIX PLUS and OSSIX VOLUMAX must not be used in:
    • Patients with known collagen hypersensitivity
    • Patients with a sensitivity to porcine-derived materials
    • Patients suffering from autoimmune disease and connective tissue disease, such as systemic lupus erythematosus, dermatomyositis, etc.
  • OSSIX PLUS and OSSIX VOLUMAX are intended for use as a single use device. Do not resterilize.
  • Treatment of high risk patients, such as smokers and patients with uncontrolled diabetes or periodontal disease, may be impaired. Infection control and good oral hygiene should be achieved prior to surgical intervention.
  • Clinical and post marketing experience with Ossix, the bovine counterpart, reveals an excellent safety profile during long-term experience. Adverse reactions with a porcine collagen membrane were not observed. Yet, as the membrane is of a collagen origin, allergic reactions (e.g., erythema, swelling, induration and/or pruritus at treatment site) may not be entirely excluded.

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INDICATION FOR OSSIX GRAFT | PARTICULATE ALLOGRAFT

OSSIX GRAFT Particulate Allograft products consist of cortical bone matrix and may be used in a variety of reconstructive, periodontal, and oral maxillofacial procedures. OSSIX GRAFT contains Human Cellular and Tissue Based Product (HCT/P).

    IMPORTANT SAFETY INFORMATION FOR OSSIX GRAFT
  • OSSIX GRAFT is contraindicated in:
    • Active or latent infection at the surgical implantation site.
    • Sensitivity or allergies to any of the processing agents listed under the Processing section of the Instructions for Use. Processing agents may include some or all of the following: Bacitracin, Polymyxin B Sulfate, Gentamicin, Allowash, alcohol and/or hydrogen peroxide.
    • Use in immunocompromised patients.
  • As with all allogeneic materials, it is not possible to provide an absolute guarantee that no infectious disease will be transmitted.
  • Single patient, single use only. Do not sterilize or re-sterilize.
  • Do not use if the packaging or labeling is damaged or has flaws. Do not use if the expiration date has been exceeded.
  • Recommended storage conditions and the maintenance of the tissue for transplantation are the responsibility of the hospital or clinician. Do not use if tissue has not been stored according to the recommended storage instructions.
  • Prior to clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the product.
  • Antibiotic acceptability must be discussed with the patient to discern patient status regarding antibiotic sensitivity.
  • Use standard practices for handling and disposal of human tissue.
  • Inherent uncertainty exists in medical and social histories and lab testing which may not detect known or unknown pathogens. Therefore, the following complications may occur with tissue transplantation:
    • Transmission of diseases of unknown etiology;
    • bacterial or fungal infection;
    • Immune rejection of implanted HCT/P; or
    • Loss of function and/or integrity of implanted HCT/P due to resorption, fragmentation, and/or disintegration.
  • Maintain documentation about the disposition of each tissue to enable tracking from the donor to the consignee or final disposition. Complete the Allograft Tracing Record (ATR) and preprinted labels included with every graft.
  • Although efforts have been made to ensure the safety of allograft material, current technologies may not preclude the transmission of disease. Adverse outcomes potentially attributable to the tissue or unanticipated or adverse events must be reported immediately to your distributor. USA: 1-800-321-4576.

Click here for Instructions for Use.

REFERENCES: 1. Zubery Y, Goldlust A, Alves A, Nir E. Ossification of a novel cross-linked porcine collagen barrier in guided bone regeneration in dogs. J Periodontol. 2007;78(1):112-121. 2. Zubery Y, Nir E, Goldlust A. Ossification of a collagen membrane cross-linked by sugar: a human case series. J Periodontol. 2008;79(6):1101-1107. 3. Zubery Y, Goldlust A, Bayer T, Woods S, Jackson N, Soskolne WA. Alveolar ridge restoration using a new sugar cross-linked collagen-hydroxyapatite matrix in canine L-shape defects. Datum Dental. Poster presented at: Academy of Osseointegration 2017 Annual Meeting; March 15-18, 2017; Orlando, FL. http://www.ossixdental.com/images/Alveolar_Ridge_Restoration_AAP_MKT0040_Ver_01_reading_flow.pdf. Accessed August 12, 2018. 4. Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011;31(5):457-469.