# K962548: BSM Bone Substitute Material Kit

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corp.
- Decided: Aug 5, 1997 after 403 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OsteoGen®: named in the summary without a submission number
- (no number) Hapset®: named in the summary without a submission number

## Most influential descendants
- K091729: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone (2009), 2 descendants of its own
- K983104: Norian Periodontal/Dental Cement (PDC) (1999), 2 descendants of its own
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own
- K100883: Carrigen (2010), 0 descendants of its own

## Indications for use
o-BSM™ Bane Substitute Material is a synthetic calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.

Source page: https://510kreport.com/device/K962548
Methodology: https://510kreport.com/methodology