# K230630: ZENEX Implant System_Narrow

- Pathway: 510(k) (Traditional)
- Applicant: Izenimplant Co., Ltd.
- Decided: Jul 31, 2023 after 146 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: 12 generations back to K960026 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161244: s-Clean OneQ-SL Narrow Implant System, Dentis Co., Ltd. (2016) Summary page 4.

## Indications for use
The ZENEX Implant System_ Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K230630
Methodology: https://510kreport.com/methodology