# K151970: KJ Mini Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech Co., Ltd.
- Decided: Oct 21, 2016 after 463 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 K960026 (1996). 120 ancestors in all.
No later device cites it as a predicate yet.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133050: One Plus Implant System, Osseofuse, Inc. (2014) Summary page 4.
- K083067: MS System, Osstem Implant Co., Ltd. (2009) Summary page 4.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 5.
- K103194: Intra-Lock Dental Implants with Blossom, Intra-Lock International, Inc. (2011) Summary page 5.
- K050970: Milo Dental Implant System, Intra-Lock International (2005) Summary page 5.
- K072959: MS System (Denture), Osstem Implant Co., Ltd. (2008) Summary page 5.

## Indications for use
The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.

Source page: https://510kreport.com/device/K151970
Methodology: https://510kreport.com/methodology