# K190637: Fit & Brilliant Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: F&B Technology Co., Ltd.
- Decided: Jun 19, 2020 after 465 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: 9 generations back to K944964 (1995). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132956: U Fit Dental Implant System, T Strong, Inc. (2014) Summary page 4.

## Indications for use
The Fit & Brilliant Dental 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 terminal or intermediate abutment support for fixed bridgework. The Fit &Brilliant Dental Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Source page: https://510kreport.com/device/K190637
Methodology: https://510kreport.com/methodology