# K241186: Synthetic Bone Graft Particulate

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dazhou Medical Technology Co., Ltd.
- Decided: Feb 21, 2025 after 298 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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 K941780 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040278: Perioglas-Bioglass Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 5.

## Indications for use
Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)

Source page: https://510kreport.com/device/K241186
Methodology: https://510kreport.com/methodology