# K960724: Bio-Gide Resorbable Bilayer Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich-Pharma
- Decided: Jun 11, 1997 after 475 days
- Product code: NPK (Barrier, Synthetic, 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
No predicates in its family tree.
73 later devices descend from it; 11 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (2004), 58 descendants of its own
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone (2005), 53 descendants of its own
- K112572: Geistlich Combi-Kit Collegen (2011), 23 descendants of its own
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic (2013), 21 descendants of its own
- K061244: Mucograft (2006), 16 descendants of its own

## Indications for use
BIO-GIDE® is indicated for: - simultaneous use GBR-membrane (BIO-GIDE®) and 4mp|ants - augmentation around implants placed in immediate extract sockets; - - augmentation around iniplants 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. Becayse of its elasticity, BIO-GIDE® has to be used in combination with space-making bone graft materials, e.g., autogenous bone, bone substitutes (BIO-OSS®, etc.)

Source page: https://510kreport.com/device/K960724
Methodology: https://510kreport.com/methodology