# K251062: 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

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Aug 14, 2025 after 132 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: 10 generations back to K924408 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Geistlich Pharma AG (2022) Summary page 11.

## 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; and » 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, and » guided tissue regeneration procedures in periodontal defects. Geistlich Bio-Gide® Forte 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, and » 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).

Source page: https://510kreport.com/device/K251062
Methodology: https://510kreport.com/methodology