# K210362: s-Clean Pre-Milled Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Aug 19, 2021 after 192 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
- K242703: LW Pre-milled Abutment (2024), 0 descendants of its own

## Indications for use
s-Clean Pre-Milled 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. No. Implant System Compatibility Implant Diameter (mm) Platform Diameter (mm) 1 s-Clean SQ-SL Fixture Ø5.8 Ø4.3 2 s-Clean SQ-SL Fixture Ø6.8 Ø4.5 s-Clean Pre-Milled Abutment is intended for use with the s-Clean SQ-SL Fixtures in the chart. All digitally designed abutments for use with s-Clean Pre-Milled Abutment are intended to be manufactured at a Dentis validated milling center.

Source page: https://510kreport.com/device/K210362
Methodology: https://510kreport.com/methodology