# K233419: GBR System

- Pathway: 510(k) (Traditional)
- Applicant: Proimtech Saglik Urunleri Anonim Sirketi
- Decided: Jan 3, 2025 after 451 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: 3 generations back to K952167 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011698: Straumann GBR System, Institut Straumann AG (2001) Summary page 7.

## Indications for use
The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone grafts, bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.

Source page: https://510kreport.com/device/K233419
Methodology: https://510kreport.com/methodology