# K200193: Kisses Plus Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Achimhai Medical Corporation
- Decided: Aug 6, 2021 after 557 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894595 (1990). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 4.
- K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 4.
- K112045: Simpleline II Abutment System, Dentium Co., Ltd. (2012) Summary page 4.

## Indications for use
The Kisses Plus Implant System 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 Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.

Source page: https://510kreport.com/device/K200193
Methodology: https://510kreport.com/methodology