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New Device Approval

GEM 21S (Growth-factor Enhanced Matrix) - P040013

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: GEM 21S (Growth-factor Enhanced Matrix)
PMA Applicant: Biomimetics Pharmaceuticals Incorporated
Address: 389-A Nichol Mill Lane, Franklin, Tennessee 37067
Approval Date: November 18, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/P040013a.pdf

What is it? GEM 21S is a dental bone filling device with a biological component that is used to treat patients who have bone defects due to periodontal disease.

How does it work? GEM 21S provides a structure for bone growth and the biological component encourages bone to grow.

When is it used? GEM 21S may be used in patients who have bone defects due to periodontal disease.

What will it accomplish? GEM 21S may fill in the bone defects in a shorter time than products without the biological component.

When should it not be used? GEM 21S is should not be used in patients who:

• have an infection or a cancerous growth in the defect area
• do not have enough gum tissue to cover the bone filling device
• are allergic to any of the components.

Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.fda.gov/cdrh/pdf4/p040013.html

Updated November 29, 2005

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