# K090950: Bone Plus BCP

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Jul 2, 2010 after 455 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: 5 generations back to K990131 (1999). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051885: MBCP, Biomatlante (2005)
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005)
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998)

## Most influential descendants
- K122240: Bone Plus BCP Eagle Eye (2012), 0 descendants of its own

## Indications for use
Bone PlusTM BCP is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. * Augmentation or reconstructive treatment of alveolar ridge * Filling of periodontal defects * Filling of defects after root resection, apicocectomy, and cystectomy * Filling of extraction sockets to enhance preservation of the alveolar ridge * Elevation of maxillary sinus floor * Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) * Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration

Source page: https://510kreport.com/device/K090950
Methodology: https://510kreport.com/methodology