# K210132: s-Clean SQ-SL Implant System Regular

- Pathway: 510(k) (Special)
- Applicant: Dentis Co., Ltd.
- Decided: Feb 17, 2021 after 29 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: 15 generations back to K894595 (1990). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192688: s-Clean SQ-SL Implant System Regular, Dentis Co., Ltd. (2020) Summary page 4.

## Indications for use
s-Clean SQ-SL Implant System Regular 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/K210132
Methodology: https://510kreport.com/methodology