# K981182: Osteograf/N-300

- Pathway: 510(k) (Traditional)
- Applicant: Ceramed Dental, LLC
- Decided: Jul 2, 1998 after 92 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bio-Oss: named in the summary without a submission number

## Most influential descendants
- K090793: Bongros HA (2009), 0 descendants of its own
- K071817: Osteograf/N-300 (2007), 0 descendants of its own

## Indications for use
The intended use of OsteoGraf/N-300 is for: - Treatment of infrabony periodontal defects. - Augmentation of bony defects of the alveolar ridge. - Filling of extraction sites. - Sinus elevation grafting.

Source page: https://510kreport.com/device/K981182
Methodology: https://510kreport.com/methodology