# K122240: Bone Plus BCP Eagle Eye

- Pathway: 510(k) (Special)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Aug 21, 2012 after 25 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: 6 generations back to K990131 (1999). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090950: Bone Plus BCP, Megagen Implant Co., Ltd. (2010) Summary page 3.

## Indications for use
Bone PlusTM BCP Eagle Eye 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 peni-implant defects in conjunction with products intended for Guided Bone Regeneration

Source page: https://510kreport.com/device/K122240
Methodology: https://510kreport.com/methodology