# K201546: OsOpia Synthetic Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Revisios BV
- Decided: Oct 2, 2020 after 115 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: 2 generations back to K860983 (1986). 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)
- K042706: Ossatura Dental, Isotis Orthobiologics, Inc. (2004) Summary page 5.

## Indications for use
OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.

Source page: https://510kreport.com/device/K201546
Methodology: https://510kreport.com/methodology