# K974399: Bio-Oss Collagen

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich-Pharma
- Decided: Sep 16, 1998 after 299 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.
172 later devices descend from it; 12 cite it directly.
0 of 173 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
- K012751: Healos Bone Graft Material (2001), 84 descendants of its own
- K043308: Modification to: Healos Bone Graft Material (2005), 67 descendants of its own
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K043034: Osteoguide Anorganic Bone Mineral Products (2005), 55 descendants of its own

## Indications for use
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicoectomy, and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration(GTR) and Guided Bone Regeneration (GBR) Filling of peri-implant defects in-conjunction with. products intended for Guided Bone Regeneration (GBR)

Source page: https://510kreport.com/device/K974399
Methodology: https://510kreport.com/methodology