# K973924: Frios Boneshield

- Pathway: 510(k) (Traditional)
- Applicant: Friatec AG
- Decided: May 7, 1998 after 204 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Friatec Bone Shield is indicated for use for insuring three dimensional reconstruction of alveolar bone defects and Facilitating augmentation with adequate fixation of the augmentation material.

Source page: https://510kreport.com/device/K973924
Methodology: https://510kreport.com/methodology