# K231513: Oral Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
- Decided: Feb 16, 2024 after 267 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: 3 generations back to K010952 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161762: DynaMatrix/Dynamatrix Plus, Cook Biotech Incorporated (2017) Summary page 7.

## Indications for use
The Oral Matrix is intended for use in extraction sockets only 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/K231513
Methodology: https://510kreport.com/methodology