# K132992: TI Star Implant System

- Pathway: 510(k) (Traditional)
- Applicant: T-Plus Implant Tech. Co., Ltd.
- Decided: Dec 18, 2013 after 85 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: 7 generations back to K944964 (1995). 54 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052369: Exfeel Implant System, Megagen Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K152787: ST Internal Fixture System (2016), 2 descendants of its own
- K190919: ST Internal Implant System (2020), 0 descendants of its own
- K171197: Zuga Dental Implant System (2018), 0 descendants of its own

## Indications for use
The Ti Star Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The Ti Star Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K132992
Methodology: https://510kreport.com/methodology