# K103820: Reprobone Dental Grafting Material

- Pathway: 510(k) (Traditional)
- Applicant: Ceramisys, Ltd.
- Decided: Nov 3, 2011 after 308 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: 7 generations back to K990131 (1999). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.
- K082286: Bioactys, Graftys (2009) Summary page 1.
- K051885: MBCP, Biomatlante (2005) Summary page 1.

## Indications for use
ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge. Filling of infrabony periodontal defects, Filling of defects after root resection apicoectomy and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. Filling of periodontal defects in conjunction with products intended for guided tissue regeneration (GTR) and guided bone regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).

Source page: https://510kreport.com/device/K103820
Methodology: https://510kreport.com/methodology