# K071817: Osteograf/N-300

- Pathway: 510(k) (Special)
- Applicant: Dentsply Interntional
- Decided: Sep 4, 2007 after 63 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: 1 generation back to K902295 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981182: Osteograf/N-300, Ceramed Dental, LLC (1998) Summary page 1.
- K960348: Osteograf/N-300 Hydroxylapatite, Ceramed Corp. (1996) Summary page 1.
- K902295: Osteograf/N Natural Hydroxylapatite, 40-60 Mesh, Ceramed Corp. (1990) Summary page 1.

## Indications for use
OsteoGraf/N-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting,

Source page: https://510kreport.com/device/K071817
Methodology: https://510kreport.com/methodology