# K251818: Bontree Plus

- Pathway: 510(k) (Traditional)
- Applicant: Hudens Bio Co., Ltd.
- Decided: Mar 6, 2026 after 266 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: 7 generations back to K990131 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112716: Osteon II, Genoss Co., Ltd. (2012) Summary page 5.

## Indications for use
BONTREE PLUS is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects, including - Periodontal/infrabony defects - Ridge augmentation - Extraction sites (implant preparation/placement) - Sinus lifts - Cystic cavities

Source page: https://510kreport.com/device/K251818
Methodology: https://510kreport.com/methodology