# K153639: OneQ-SL s-Clean Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Apr 8, 2016 after 109 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). 97 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073486: Dentis Dental Implant System, Dentis Co., Ltd. (2008) Summary page 4.
- K150344: Dentis Dental Implant System, Dentis Co., Ltd. (2015) Summary page 4.
- K142313: OneQ-SL Implant System, Dentis Co., Ltd. (2015) Summary page 6.
- K063216: Rescue Internal Implant System, Megagen Co., Ltd. (2007) Summary page 6.

## Most influential descendants
- K192688: s-Clean SQ-SL Implant System Regular (2020), 3 descendants of its own
- K210134: Dentis s-Clean s-Line (2021), 2 descendants of its own
- K212517: Magicore System (2021), 1 descendant of its own
- K200099: s-Clean SQ-SL Implant System Mini (2020), 1 descendant of its own
- K253493: Dentis SQ-SL AXEL Fixture (2026), 0 descendants of its own

## 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/K153639
Methodology: https://510kreport.com/methodology