# K161762: DynaMatrix/Dynamatrix Plus

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech Incorporated
- Decided: Jan 13, 2017 after 200 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 K010952 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082058: Dynamatrix, Cook Biotech, Inc. (2008) Summary page 4.

## Most influential descendants
- K231513: Oral Matrix (2024), 0 descendants of its own

## Indications for use
DynaMatrix is intended for use in guided tissue regeneration and 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 or prevent migration of graft material. The device is supplied sterile and intended for one-time use.

Source page: https://510kreport.com/device/K161762
Methodology: https://510kreport.com/methodology