# 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

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Apr 5, 2022 after 242 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: 9 generations back to K924408 (1995). 26 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Geistlich Pharma AG (2019) Summary page 9.

## Most influential descendants
- K253317: Cytrans™ Elashield (2026), 0 descendants of its own
- 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 (2025), 0 descendants of its own
- K250833: SwissMembrane X; SwissMembrane X Socket (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@ 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@ 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@ 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/K212463
Methodology: https://510kreport.com/methodology