# K970569: Bio-Blocks

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich-Pharma
- Decided: Aug 14, 2000 after 1,294 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.
125 later devices descend from it; 2 cite it directly.
0 of 126 devices 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.

## Most influential descendants
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen (2004), 124 descendants of its own
- K043034: Osteoguide Anorganic Bone Mineral Products (2005), 55 descendants of its own
- K052812: Ossimend (TM) Bone Graft Material (2006), 40 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own

## Indications for use
Augmentation of reconstructive treatment of the alveolar ridge Filling of defects after root resection, apicoectomy and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge

Source page: https://510kreport.com/device/K970569
Methodology: https://510kreport.com/methodology