# K222367: Save GBR

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Mar 23, 2023 after 230 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K761228 (1976). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170697: GBR system, Surgident (2018) Summary page 4.

## Indications for use
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

Source page: https://510kreport.com/device/K222367
Methodology: https://510kreport.com/methodology