# K230523: s-Clean Link Abutment Narrow

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: May 24, 2023 after 86 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: 16 generations back to K894844 (1990). 219 ancestors in all.
No later device cites it as a predicate yet.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222913: s-Clean Link Abutment, Dentis Co., Ltd. (2023) Summary page 4.

## Indications for use
s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors. s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.

Source page: https://510kreport.com/device/K230523
Methodology: https://510kreport.com/methodology