# K093122: MBCP+

- Pathway: 510(k) (Traditional)
- Applicant: Biomatlante
- Decided: Mar 15, 2010 after 164 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042706: Ossatura Dental, Isotis Orthobiologics, Inc. (2004) Summary page 2.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 2.
- K051885: MBCP, Biomatlante (2005) Summary page 2.

## Indications for use
MBCP+TM is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP+TM 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/K093122
Methodology: https://510kreport.com/methodology