# K042706: Ossatura Dental

- Pathway: 510(k) (Traditional)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Oct 20, 2004 after 20 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.
6 later devices descend from it; 4 cite it directly.
0 of 9 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
- K082419: Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 (2009), 2 descendants of its own
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own
- K201546: OsOpia Synthetic Bone Void Filler (2020), 0 descendants of its own
- K093122: MBCP+ (2010), 0 descendants of its own

## Indications for use
OsSaturaT m Dental is a bone filling material indicated for augmentation or reconstructive treatment of the 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 - Treatment of periodontal defects

Source page: https://510kreport.com/device/K042706
Methodology: https://510kreport.com/methodology