# K110449: Endobon Xenograft Granules

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i
- Decided: May 13, 2011 after 86 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) BioOss (Xenograft Bone Granules (Bovine)): named in the summary without a submission number

## Recalls of this device
- Jan 21, 2016 · Class II · Z-0788-2016: Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.

## Indications for use
Endobon® Xenograft Granules are used in the following dental and/or surgical procedures: Alveolar ridge augmentation/reconstruction. Filling of defects after root resection, apicoectomy, and cystectomy. Filling alveoli after tooth extraction. Sinus elevation. This product should not be used in non-peridontal mandibular applications.

Source page: https://510kreport.com/device/K110449
Methodology: https://510kreport.com/methodology