# K072058: Modification to: Osteograf/N-700

- Pathway: 510(k) (Special)
- Applicant: Dentsply Interntional
- Decided: Aug 3, 2007 after 8 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 K921469 (1992). 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)
- K981214: Osteograf/N-700, Ceramed Dental, LLC (1998) Summary page 1.
- K960368: Osteograft/N-700 Hydroxylaptite, Ceramed Corp. (1996) Summary page 1.
- K921469: Osteograf/N-700 Natural Hydroxylapatite 18-40 Mesh, Ceramed Corp. (1992) Summary page 1.

## Indications for use
OsteoGraf/N-700 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting. These are the same indications for use previously cleared for K981214, K960368, K921469

Source page: https://510kreport.com/device/K072058
Methodology: https://510kreport.com/methodology