# K960164: Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Interfaces, Inc.
- Decided: Apr 10, 1996 after 85 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) allogeneic freeze-dried bone: named in the summary without a submission number
- (no number) Bii-GRAFT™ 1860: named in the summary without a submission number
- (no number) Osteograf-LD™ synthetic materials: named in the summary without a submission number

## Most influential descendants
- K040646: Straumann Granules (2004), 2 descendants of its own
- K201051: Straumann BoneCeramic (2020), 0 descendants of its own
- K050170: Fortoss Vital Bone Graft Substitute (2005), 0 descendants of its own

## Indications for use
for filing and contouring osseous defects such as periodontal lesions

Source page: https://510kreport.com/device/K960164
Methodology: https://510kreport.com/methodology