# K082058: Dynamatrix

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Oct 2, 2008 after 73 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: 1 generation back to K010952 (2002). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010952: Surgisis Guided Tissue Regeneration Matrix, Cook Biotech, Inc. (2002)

## Most influential descendants
- 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
- 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

## Indications for use
DynaMatrixTM is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.

Source page: https://510kreport.com/device/K082058
Methodology: https://510kreport.com/methodology