Augmented Gingival Matrix

The Augmented Gingival Matrix (AGM) is a three-layer composite matrix composed of bovine gelatin outer and inner layers with a polycaprolactone (PCL) middle layer. It is indicated for localized gingival augmentation to increase keratinized tissue around teeth. The gelatin layers promote tissue regeneration while the PCL layer acts as a physical barrier and aids matrix spreading on the wound surface.

AGM uses bovine bone-derived gelatin (versus porcine sources in the predicate) and includes a non-animal-derived PCL middle layer. The gelatin is partially absorbed during product lifetime while PCL persists. AGM is sterilized by ethylene oxide (versus gamma irradiation for the predicate) and has a 2-year shelf life. Device sizes range from 10–30 mm width and 10–40 mm length, falling within the predicate's range.

ISO 15901-1:2016 (porosity), ISO 7198:2016 (tearing force), ISO 10993 series (biocompatibility including cytotoxicity, sensitization, implantation, genotoxicity), ISO 10993-7:2008 (sterilization residuals), USP monographs (pH, heavy metals, sterility, endotoxins), and ISO 22442-3 (viral inactivation).

AGM is substantially equivalent to Geistlich Mucograft® (K210280) because both are Class II barrier materials for bone grafting and oral tissue regeneration. Although AGM uses different source materials and has different resorbability, non-clinical and clinical data demonstrate comparable safety and efficacy, with the clinical study showing non-inferior keratinized gingival width augmentation at 6 months postoperatively versus autologous free gingiva.