# K112540: S-Mini Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Feb 3, 2012 after 155 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: 11 generations back to K960026 (1996). 26 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080594: MS System (Narrow Ridge), Osstem Implant Co., Ltd. (2008) Summary page 2.
- K051018: Intermezzo Implant Systems, Megagen Co., Ltd. (2005) Summary page 2.
- K072959: MS System (Denture), Osstem Implant Co., Ltd. (2008) Summary page 2.
- K080126: Dio Protem Implant System, Dio Department Dsi, Inc. (2008) Summary page 2.

## Most influential descendants
- K133050: One Plus Implant System (2014), 1 descendant of its own
- K241127: INNO SLA Mini Plus® Implant System (2024), 0 descendants of its own
- K181178: S-mini active Fixture (2018), 0 descendants of its own
- K170394: Kisses Mini (2017), 0 descendants of its own
- K151970: KJ Mini Implant System (2016), 0 descendants of its own

## Indications for use
The S-MiNi Implant System is divided into two types: - Cement Type The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients. - Ball Type The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.

Source page: https://510kreport.com/device/K112540
Methodology: https://510kreport.com/methodology