# K230246: Dentis s-Clean SQ-SL Narrow Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: May 25, 2023 after 115 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K960026 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

Source page: https://510kreport.com/device/K230246
Methodology: https://510kreport.com/methodology