# K142313: OneQ-SL Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Dec 10, 2015 after 478 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: 12 generations back to K894595 (1990). 46 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 5.

## Most influential descendants
- K153639: OneQ-SL s-Clean Implant System (2016), 14 descendants of its own
- K171027: Dentis Dental Implant System (2017), 5 descendants of its own
- 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
- K171694: s-Clean TiN Coating Abutments (2017), 2 descendants of its own

## Indications for use
The OneQ-SL 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 intended for delayed loading.

Source page: https://510kreport.com/device/K142313
Methodology: https://510kreport.com/methodology