# K092194: Polybone Dental

- Pathway: 510(k) (Traditional)
- Applicant: Kyung Won Medical Co., Ltd.
- Decided: Jun 16, 2010 after 330 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 K941780 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053374: Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM), Ossacur AG (2006) Summary page 1.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 1.

## Indications for use
PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K092194
Methodology: https://510kreport.com/methodology