Unique cross-linking technology*

*Excludes OSSIX™ Graft.

OSSIX™ products provide excellent biocompatibility and bio-durability.

LEARN HOW

Image of collagen used in cross-linking technology

To order any OSSIX™ product, call OraPharma at 866-273-7846

REFERENCES: 1. 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 May 23, 2018. 2. Friedmann A, Dehnhardt J, Kleber B, Bernimoulin, J. Cytobiocompatibility of collagen and ePTFE membranes on osteoblast-like cells in vitro. J Biomed Materials Res A. 86A(4)935-941.

INDICATION FOR OSSIX™ Bone BONE GRAFTING MATERIAL

OSSIX 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:

  • 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.

Click here for Instructions for Use.

INDICATION FOR OSSIX PLUS® RESORBABLE COLLAGEN MEMBRANE

OSSIX PLUS biodegradable collagen membrane is intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

Important safety Information:

  • OSSIX PLUS 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 is 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.

Click here for Instructions for Use.

INDICATION FOR OSSIX™ Volumax RESORBABLE COLLAGEN MEMBRANE

OSSIX VOLUMAX biodegradable collagen membrane is intended for use during the process of guided tissue regeneration (GTR) and guided bone regeneration (GBR) as a biodegradable barrier.

IMPORTANT SAFETY INFORMATION:

  • 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 VOLUMAX is 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.

Click here for Instructions for Use.

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:

  • 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.