# K192747: Yxoss CBR®

- Pathway: 510(k) (Traditional)
- Applicant: Reoss GmbH
- Decided: Jun 17, 2020 after 261 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894595 (1990). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172354: OssBuilder System, Osstem Implant Co., Ltd. (2018) Summary page 4.

## Indications for use
Yxoss CBR® is used for reconstruction of alveolar bone deficits prior to placing a dental implant, shaping alveolar bone and as a support to the augmented bone volume in the regeneration of bone defects that may include: • extraction sites • horizontal and/or vertical augmentation of the alveolar ridge • reconstruction of bone defects in the maxillofacial area

Source page: https://510kreport.com/device/K192747
Methodology: https://510kreport.com/methodology