# K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration

- Pathway: 510(k) (Traditional)
- Applicant: Ed. Geistlich Soehne AG Fuer Chemische Industrie
- Decided: Nov 15, 2004 after 94 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: 2 generations back to K924408 (1995). 3 ancestors in all.
58 later devices descend from it; 12 cite it directly.
0 of 62 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 1.
- K992216: Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane, Integra Lifesciences Corp. (1999) Summary page 2.

## Most influential descendants
- 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
- K073711: Mucograft Collagen Matrix (2008), 15 descendants of its own

## Indications for use
Simultaneous use of GBR-membrane and implants; 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/K042197
Methodology: https://510kreport.com/methodology