# K202675: InRoad® Dental Synthetic Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Osteogene Tech Corp
- Decided: Mar 4, 2022 after 535 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: 3 generations back to K852742 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102872: Osbone Dental, Curasan AG (2011) Summary page 4.

## Indications for use
InRoad® Dental Synthetic Bone Graft is intended for the filling and reconstruction of multi-walled bone defects such as: - Defects after removal of bone cysts - Augmentation of the atrophied alveolar ridge - Sinus lift and sinus floor elevation (subantral augmenation) - Filling of alveolar defects following tooth extraction for alveolar ridge preservation - Filling of extraction defects to create an implant bed - Filling of two- or multi- walled infra-bony pockets. and bi- and trifurcation defects - Support function for a membrane in controlled tissue regeneration (CTR) - Defects after surgical removal of retained teeth or corrective osteotomies - Other multi-walled bone defects of the alveolar processes

Source page: https://510kreport.com/device/K202675
Methodology: https://510kreport.com/methodology