# K031813: Ossatura Dental

- Pathway: 510(k) (Traditional)
- Applicant: Isotis NV
- Decided: Aug 20, 2004 after 435 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 K860983 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K860983: Interpore 200 Porous Hydroxyapatite, Interpore Intl. (1986) Summary page 1.
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 1.

## Most influential descendants
- K090850: Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute (2009), 0 descendants of its own

## Indications for use
OsSaturaTM Dental is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes: - filling of defects after root resection, apicoectomy, and cystectomy - filling of extraction sockets to enhance preservation of the alveolar ridge - elevation of maxillary sinus floor

Source page: https://510kreport.com/device/K031813
Methodology: https://510kreport.com/methodology