# K170394: Kisses Mini

- Pathway: 510(k) (Traditional)
- Applicant: Achimhai Medical Corporation
- Decided: Oct 6, 2017 after 240 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 K894595 (1990). 176 ancestors in all.
No later device cites it as a predicate yet.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150537: MiNi Internal Implant System, Megagen Implant Co., Ltd. (2015) Summary page 5.
- K112540: S-Mini Implant System, Neobiotech Co., Ltd. (2012) Summary page 5.

## Indications for use
The Kisses Mini is indicated for use in partially or fully edentulous mandibles and maxilla, 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 Kisses Mini is for single and two stage surgical procedures. It is for delayed loading. The intended use of the 3.2 mm Internal Hex fixtures is limited to the replacement of maxillary lateral incisors and mandibular incisors. The intended use of the single-piece post type fixture is limited to replacement of mandibular central and lateral incisors. The ball-type single-piece implant is intended for stabilization and retention of overdentures.

Source page: https://510kreport.com/device/K170394
Methodology: https://510kreport.com/methodology