# K212702: IM/ST Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Fiteeth Medical Instrument Co., Ltd.
- Decided: Oct 13, 2022 after 413 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: 13 generations back to K894595 (1990). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121995: TS Fixture System, Osstem Implant Co., Ltd. (2012) Summary page 6.

## Most influential descendants
- K250280: SD TL Implant System (2025), 0 descendants of its own

## Indications for use
The IM/ST Fixture 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.

Source page: https://510kreport.com/device/K212702
Methodology: https://510kreport.com/methodology