# K254286: Guided Bone Regeneration System

- Pathway: 510(k) (Traditional)
- Applicant: DentalMaster (Xiamen)Medical Technology Co., Ltd.
- Decided: Aug 24, 2026 after 236 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: 2 generations back to K080430 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201210: The Micro Screw System, Micro Screw System Basic, Hager& Meisinger GmbH (2021) Summary page 5.

## Indications for use
The Guided Bone Regeneration System is indicated for the fixation and stabilization of bone grafts and bone filling materials in alveolar bone defects during alveolar bone augmentation procedures.

Source page: https://510kreport.com/device/K254286
Methodology: https://510kreport.com/methodology