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GEM 21S®
Growth-Factor Enhanced Matrix for Periodontal Regeneration
Details
Device typePeriodontal root surface regeneration material: A bioabsorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support. It is typically presented in the form of a gel, or as a solution and enamel matrix material that is mixed into a gel prior to application. This is a single-use device.
FDA categoryBiologic Material, Dental, Bone Grafting Material, Dental, With Biologic Component
Device ID00850001118002
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Weight0.5 Gram