# K160991: Neo GBR System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Jan 10, 2017 after 277 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: 7 generations back to K894844 (1990). 41 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143730: GBR System, Jeil Medical Corporation (2015) Summary page 5.

## Most influential descendants
- K181854: OssBuilder System (2019), 0 descendants of its own

## Indications for use
Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

Source page: https://510kreport.com/device/K160991
Methodology: https://510kreport.com/methodology