# K111105: Curasan Osseolive Dental

- Pathway: 510(k) (Abbreviated)
- Applicant: Curasan AG
- Decided: Dec 20, 2012 after 610 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 K960978 (1996). 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)
- K053387: Perioglas Bone Graft Particulate, Novabone Products, LLC (2006) Summary page 2.
- K103709: Ceracell Dental, Curasan AG (2011) Summary page 2.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 3.

## Indications for use
Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.: * Defects after the extirpation of bone cysts * Augmentation of an atrophied alveolar ridge * Sinus lift or sinus floor elevation (subantral augmentation) * Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge * Filling of extraction defects to create an implant bed * Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects * Defects after operative removal of retained teeth or corrective osteotomies

Source page: https://510kreport.com/device/K111105
Methodology: https://510kreport.com/methodology