# K112572: Geistlich Combi-Kit Collegen

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Dec 28, 2011 after 113 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- 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: 4 generations back to K924408 (1995). 14 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092428: Bio-Oss Collagen, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2010) Summary page 2.
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 2.
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 2.
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 2.
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2004) Summary page 2.
- K960724: Bio-Gide Resorbable Bilayer Membrane, Geistlich-Pharma (1997) Summary page 2.
- K970321: Bio-Oss Anorganic Bovine Bone, Geistlich-Pharma (1998) Summary page 2.
- K952618: Bio-Oss, Geistlich-Pharma (1995) Summary page 2.

## Most influential descendants
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic (2013), 21 descendants of its own
- 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
- K240661: Geistlich Bio-Oss® (2024), 2 descendants of its own

## Indications for use
Geistlich Combi-Kit Collagen is a convenience kit that provides one (1) unit Geistlich Bio-Gide® resorbable bilayer collagen membrane and one (1) unit Geistlich Bio-Oss Collagen® block in one (1) package. 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-Oss® is intended for the following uses: - Augmentation or reconstructive treatment of the alveolar ridge; - Filling of infrabony 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/K112572
Methodology: https://510kreport.com/methodology