# K033098: Osteogen SBRG

- Pathway: 510(k) (Traditional)
- Applicant: Impladent, Ltd.
- Decided: Apr 27, 2004 after 211 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
As an aid in sinus augmentation (sinus lift) procedures. As an aid in the augmentation of tooth sockets and the treatment of alveolar ridge deformities, including peri-implant alveolar defects. As an aid in the treatment of periapical and periodontal defects.

Source page: https://510kreport.com/device/K033098
Methodology: https://510kreport.com/methodology