# K161244: s-Clean OneQ-SL Narrow Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Dec 7, 2016 after 218 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: 11 generations back to K960026 (1996). 21 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093321: Biohorizons Laser-Lok 3.0 Implant System, BioHorizons Implant Systems, Inc. (2010) Summary page 6.

## Most influential descendants
- K182448: AnyRidge Octa 1 Implant System (2019), 9 descendants of its own
- K171027: Dentis Dental Implant System (2017), 5 descendants of its own
- K203240: AccelX Abutments (2021), 2 descendants of its own
- K171694: s-Clean TiN Coating Abutments (2017), 2 descendants of its own
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own

## Indications for use
The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K161244
Methodology: https://510kreport.com/methodology