INDICATION
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.
Please see accompanying Instructions for Use or Click here for Instructions for Use.
INDICATION
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 Plus® reveals an excellent safety profile. Adverse reactions with OSSIX Plus® 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.
Please see accompanying Instructions for Use Click here for Instructions for Use.
INDICATION
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 Plus®, which is a thinner version of the membrane, reveals an excellent safety profile. Adverse reactions with OSSIX Plus® 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.
Please see accompanying Instructions for Use Click here for Instructions for Use.
