Federal Register Notice: FDA has determined the regulatory review period for GEM 21S Growth Factor Enhanced Matrix is 1,361 days for extending a patent which claims the medical device. The GEM is indicated to treat the following periodontally related defects: (1) Intrabony periodontal defects, (2) furcation periodontal defects, and (3) gingival recession associated with periodontal defects. To view this notice, click here.
