# K192042: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal - Pathway: 510(k) (Special) - Applicant: Geistlich Pharma AG - Decided: Aug 29, 2019 after 29 days - Product code: NPL (Barrier, Animal Source, Intraoral) - Device class: 2 - Regulation: 21 CFR 872.3930 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 8 generations back to K924408 (1995). 25 ancestors in all. 9 later devices descend from it; 3 cite it directly. 0 of 35 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K960724: Bio-Gide Resorbable Bilayer Membrane, Geistlich-Pharma (1997) Summary page 10. - K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2004) Summary page 10. - K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 10. - K112572: Geistlich Combi-Kit Collegen, Geistlich Pharma AG (2011) Summary page 10. - K171643: Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Pharma AG (2017) Summary page 13. - K112575: Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio, Geistlich Pharma AG (2011) Summary page 19. - K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic, Geistlich Pharma AG (2013) Summary page 22. - K140518: Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM Diameter, Geistlich Pharma AG (2014) Summary page 30. - K102531: Mucograft, Ed. Geistlich Soehne AG Fur Chemische Industrie (2010) Summary page 30. ## Most influential descendants - K212463: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack (2022), 3 descendants of its own - K210280: Geistlich Mucograft®, Geistlich Mucograft® Seal (2021), 3 descendants of its own - K253317: Cytrans™ Elashield (2026), 0 descendants of its own - K250512: Augmented Gingival Matrix (2025), 0 descendants of its own - K252253: Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (2025), 0 descendants of its own ## Indications for use Geistlich Bio-Gide® is intended for the following uses: * augmentation around implants placed in immediate extraction sockets; * augmentation around implants placed in delayed extraction sockets; * localized ridge augmentation for later implantation; * alveolar ridge reconstruction for prosthetic treatment; * filling of bone defects after root resection, cystectomy, removal of retained teeth; * guided bone regeneration in dehiscence defects; and * guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Gide® Shape is indicated for: * augmentation around implants placed in immediate extraction sockets. * augmentation around implants placed in delayed extraction sockets. * localized ridge augmentation for later implantation. * alveolar ridge reconstruction for prosthetic treatment. * filling of bone defects after root resection, cystectomy, removal of retained teeth. * guided bone regeneration in dehiscence defects. Geistlich Bio-Gide® Compressed is indicated for: * augmentation around implants placed in immediate extraction sockets. * augmentation around implants placed in delayed extraction sockets. * localized ridge augmentation for later implantation. * alveolar ridge reconstruction for prosthetic treatment. * filling of bone defects after root resection, cystectomy, removal of retained teeth. * guided bone regeneration in dehiscence defects. * guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Gide® Perio is intended for the following uses: * augmentation around implants placed in immediate extraction sockets; * augmentation around implants placed in delayed extraction sockets; * localized ridge augmentation for later implantation; * alveolar ridge reconstruction for prosthetic treatment; * filling of bone defects after root resection, cystectomy, removal of retained teeth; * guided bone regeneration in dehiscence defects; and * guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Gide® is intended for the following uses: * augmentation around implants placed in immediate extraction sockets; * augmentation around implants placed in delayed extraction sockets; * localized ridge augmentation for later implantation; * alveolar ridge reconstruction for prosthetic treatment; * filling of bone defects after root resection, cystectomy, removal of retained teeth; * guided bone regeneration in dehiscence defects; and * guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Oss Collagen® is intended for the following uses: * augmentation or reconstructive treatment of the alveolar ridge; * filling of periodontal defects; * filling of defects after root resection, apicoectomy, and cystectomy; * filling of extraction sockets to enhance preservation of the alveolar ridge; * elevation of the maxillary sinus floor; * filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and * filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Geistlich Bio-Gide® Perio is intended for the following uses: * augmentation around implants placed in immediate extraction sockets; * augmentation around implants placed in delayed extraction sockets; * localized ridge augmentation for later implantation; * alveolar ridge reconstruction for prosthetic treatment; * filling of bone defects after root resection, cystectomy, removal of retained teeth; * guided bone regeneration in dehiscence defects; and * guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Oss Collagen® is intended for the following uses: * augmentation or reconstructive treatment of the alveolar ridge; * filling of periodontal defects; * filling of defects after root resection, apicoectomy, and cystectomy; * filling of extraction sockets to enhance preservation of the alveolar ridge; * elevation of the maxillary sinus floor; * filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and * filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for: * covering of implants placed in immediate or delayed extraction sockets; * localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants; * alveolar ridge reconstruction for prosthetic treatment; and * recession defects for root coverage. Source page: https://510kreport.com/device/K192042 Methodology: https://510kreport.com/methodology