# K170220: OneQ-SL s-Clean Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Apr 27, 2017 after 92 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: 14 generations back to K894595 (1990). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153639: OneQ-SL s-Clean Implant System, Dentis Co., Ltd. (2016) Summary page 4.
- K161244: s-Clean OneQ-SL Narrow Implant System, Dentis Co., Ltd. (2016) Summary page 5.
- K150344: Dentis Dental Implant System, Dentis Co., Ltd. (2015) Summary page 4.

## Indications for use
The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K170220
Methodology: https://510kreport.com/methodology