# K222913: s-Clean Link Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Jan 13, 2023 after 109 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: 15 generations back to K894844 (1990). 218 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181037: DIO CAD/CAM Abutment, Dio Corporation (2018) Summary page 4.

## Most influential descendants
- K230523: s-Clean Link Abutment Narrow (2023), 0 descendants of its own

## Indications for use
s-Clean Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.

Source page: https://510kreport.com/device/K222913
Methodology: https://510kreport.com/methodology