# K030195: BBP Bone Substitutes

- Pathway: 510(k) (Traditional)
- Applicant: Oct, USA, Inc.
- Decided: Jun 17, 2004 after 513 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
The BBPTM Bone Substitute is a bone filling augmentation material used for augmentation or reconstruction of the alveolar ridge, filling of periodontal bony defects, and filling of extraction sockets to enhance preservation of alveolar ridge.

Source page: https://510kreport.com/device/K030195
Methodology: https://510kreport.com/methodology