DIRECTION FOR USE

The general principles of sterile handling and patient medication must be followed.
 

1. The membrane can be placed either dry or hydrated. If the clinician prefers the handling characteristics of the hydrated collagen, the membrane can be hydrated in sterile water or saline solution in sterile container for approximately five minutes prior to the final placement.

2. The bone defect is surgically exposed and the usual surgical procedures are undertaken.

3. The defect is filled with a space-making material, such as autogenous bone or bone substitute whenever possible.

4.The membrane is cut to the required size and shape with scissors.

5. The membrane is applied over the defect and held in place with moderate pressure. Adhesion to the bone surface is facilitated by the hydrophilic properties of the membrane.

6. Avoid overlapping or folding of the membrane.

7. Fixation of the membrane is possible due to its high tensile strength. Fixation may be indicated to avoid membrane displacement due to shear loading or mobilization.

8. Close the wound completely in order to ensure straightforward healing.

CONTRAINDICATION

Sunmax Collagen Dental Membrane should not be used in the presence of infected wounds.
Sunmax Collagen Dental Membrane should not be used in patients with a known allergy to collagen.

ADVERSE EVENTS

Due to the special physical properties an inflammatory reaction may occur in very rare cases. Possible complications which may occur with any surgery include swelling at the surgical site, flap sloughing, bleeding, local inflammation, bone loss, infection, or pain.

As the membrane is a collagen product, in very rare cases allergic reactions may occur.