# K171643: Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Oct 30, 2017 after 150 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: 5 generations back to K924408 (1995). 15 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112575: Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio, Geistlich Pharma AG (2011) Summary page 5.

## Most influential descendants
- 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 (2019), 9 descendants of its own
- 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

## Indications for use
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

Source page: https://510kreport.com/device/K171643
Methodology: https://510kreport.com/methodology