Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

Geistlich Bio-Gide® is a family of resorbable bilayer collagen membranes intended for guided tissue and bone regeneration in dental and periodontal applications, including implant augmentation, ridge reconstruction, and filling of bone defects. The membranes have a porous bone-facing surface to allow bone cell ingrowth and a dense tissue-facing surface to prevent fibrous tissue infiltration.

All devices in the family are made of porcine collagen without cross-linking and are gamma-sterilized. They are supplied in various pre-cut sizes (ranging from 13×25 mm to 40×50 mm) as single-use devices. Some variants (Shape, Compressed, Forte, Perio) offer modified handling properties or pre-shaped forms; Perio includes cutting templates. Kit versions (Combi-Kit Collagen, Perio-System Combi-Pack) combine the membrane with Geistlich Bio-Oss Collagen® bone graft material in convenience packaging.

ISO 10993-1:2018 (biocompatibility), ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017 (sterilization), ISO 11607-1/-2 (packaging), ISO 22442-3:2007 (viral safety), ASTM F2450-18 (porosity), ASTM F2150-19 (tensile strength), ASTM F2212-20 (thermal analysis, collagen degradation, molecular weight distribution).

Each device variant claims substantial equivalence to an appropriate predicate device (primarily K212463, with K171643 referenced) based on identical material composition (porcine collagen), identical sterilization method (gamma irradiation), identical or similar sizes, and identical indications for use. The submission addresses a new slaughterhouse for existing animal-source suppliers and non-significant manufacturing facility and equipment changes through comparative physical and biochemical testing (SEM, porosity, tensile strength, DSC, suture pull-out, solubility, enzymatic degradation, SDS-PAGE, hydration) plus leveraged biocompatibility, sterilization, shelf-life, and clinical data from predicate devices, demonstrating equivalent performance.