# K012423: Mucograft

- Pathway: 510(k) (Traditional)
- Applicant: Ed. Geistlich Soehne AG Fuer Chemische Industrie
- Decided: Jan 24, 2003 after 543 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
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 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
- K061244: Mucograft (2006), 16 descendants of its own
- K073711: Mucograft Collagen Matrix (2008), 15 descendants of its own
- K102531: Mucograft (2010), 13 descendants of its own
- K140518: Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM Diameter (2014), 10 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

## Indications for use
INDICATIONS: MUCOGRAFT@ is indicated for: - simultaneous use of GBR-membrane (MUCOGRAFTB) 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.

Source page: https://510kreport.com/device/K012423
Methodology: https://510kreport.com/methodology