GEM 21S® is like no other grafting material available
GEM 21S® is a completely synthetic grafting system for bone and periodontal regeneration and is indicated to treat periodontally related defects, including:
- Intrabony defects
- Furcation defects
- Gingival recession defects associated with periodontal defects
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IMPORTANT SAFETY INFORMATION
GEM 21S® Growth-factor Enhanced Matrix is intended for use by clinicians familiar with periodontal surgical grafting techniques. It should not be used in the presence of untreated acute infections or malignant neoplasm(s) at the surgical site, where intra-operative soft tissue coverage is not possible, where bone grafting is not advisable or in patients with a known hypersensitivity to one of its components. It must not be injected systemically.
The safety and effectiveness of GEM 21S® has not been established in other non-periodontal bony locations, in patients less than 18 years old, in pregnant or nursing women, in patients with frequent/excessive tobacco use (e.g. smoking more than one pack per day) and in patients with Class III furcations or with teeth exhibiting mobility greater than Grade II. In a 180 patient clinical trial, there were no serious adverse events related to GEM 21S®, adverse events that occurred were considered normal sequelae following any periodontal surgical procedure (swelling, pain). |