# K060732: MBCP Gel

- Pathway: 510(k) (Traditional)
- Applicant: Biomatlante
- Decided: Jun 2, 2006 after 74 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). 6 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051885: MBCP, Biomatlante (2005) Summary page 2.

## Most influential descendants
- 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
- K212983: Injectable Root Canal Bioceramic Sealer (2021), 4 descendants of its own

## Indications for use
MBCP Gel T M is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP GeITM can generally be used for bone filling in closed cavities. MBCP GeITM can be used with autogenous bone grafting materials. Typical uses include but are not limited to: * Periodontal/Infrabony defects • Ridge augmentation * Extraction sites (implant preparation/placement) * Sinus lifts * Cystic cavities

Source page: https://510kreport.com/device/K060732
Methodology: https://510kreport.com/methodology