# K222451: Save GBR

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Feb 7, 2023 after 176 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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
SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Source page: https://510kreport.com/device/K222451
Methodology: https://510kreport.com/methodology