# K231967: ARi ExCon Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Dec 7, 2023 after 157 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: 14 generations back to K925765 (1993). 217 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163634: External Hex Implants, Southern Implants (Pty), Ltd. (2017) Summary page 5.

## Most influential descendants
- K241972: Bluediamond Implant (2024), 0 descendants of its own

## Indications for use
The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

Source page: https://510kreport.com/device/K231967
Methodology: https://510kreport.com/methodology