# K210134: Dentis s-Clean s-Line

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Apr 19, 2021 after 90 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). 98 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 101 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.

## Most influential descendants
- K230126: Dentis s-Clean Regular Abutment (2023), 0 descendants of its own
- K230307: Dentis i-Clean System (2023), 0 descendants of its own

## Indications for use
Dentis s-Clean s-Line 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/K210134
Methodology: https://510kreport.com/methodology