# K051885: MBCP

- Pathway: 510(k) (Traditional)
- Applicant: Biomatlante
- Decided: Sep 16, 2005 after 66 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: 4 generations back to K990131 (1999). 5 ancestors in all.
59 later devices descend from it; 14 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032268: MBCP, Biomatlante (2003) Summary page 2.
- K043005: Modification to MBCP, Biomatlante (2005) Summary page 2.

## Most influential descendants
- K060732: MBCP Gel (2006), 40 descendants of its own
- K080917: Iroot SP (2008), 37 descendants of its own
- K082943: Iroot BP, Model Irbp 4609 (2009), 12 descendants of its own
- K170175: Endoseal Mta (2018), 8 descendants of its own
- K092715: Iroot BP Plus (2009), 7 descendants of its own

## Indications for use
MBCPTM is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCPTM can be used with autogenous bone grafting materials. Typical uses include: * Periodontal/Infrabony defects * Ridge augmentation * Extraction sites (implant preparation/placement) * Sinus lifts * Cystic cavities

Source page: https://510kreport.com/device/K051885
Methodology: https://510kreport.com/methodology