# K251786: Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

- Pathway: 510(k) (Special)
- Applicant: Geistlich Pharma AG
- Decided: Jul 11, 2025 after 30 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- 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
Longest line of descent: 7 generations back to K924408 (1995). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240661: Geistlich Bio-Oss®, Geistlich Pharma AG (2024) Summary page 5.
- K120601: Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0MM Granules), Geistlich Bio-O, Geistlich Pharma AG (2012) Summary page 5.

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

Source page: https://510kreport.com/device/K251786
Methodology: https://510kreport.com/methodology