# K981214: Osteograf/N-700

- Pathway: 510(k) (Traditional)
- Applicant: Ceramed Dental, LLC
- Decided: Jun 26, 1998 after 85 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K023799: Frios Algipore (2003), 1 descendant of its own
- K072058: Modification to: Osteograf/N-700 (2007), 0 descendants of its own
- K033110: C-Graft (2003), 0 descendants of its own

## Indications for use
The intended use of OsteoGraf/N-700 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/K981214
Methodology: https://510kreport.com/methodology