# K243002: MBA Biotech Implant System

- Pathway: 510(k) (Traditional)
- Applicant: MBA Biotech Co., Ltd.
- Decided: Jun 6, 2025 after 253 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K894595 (1990). 241 ancestors in all.
No later device cites it as a predicate yet.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211090: ZENEX Implant System, Izenimplant Co., Ltd. (2022) Summary page 5.

## Indications for use
MBA Biotech Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region.

Source page: https://510kreport.com/device/K243002
Methodology: https://510kreport.com/methodology