# K171027: Dentis Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Sep 6, 2017 after 154 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: 13 generations back to K894595 (1990). 114 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073486: Dentis Dental Implant System, Dentis Co., Ltd. (2008) Summary page 4.
- K142313: OneQ-SL Implant System, Dentis Co., Ltd. (2015) Summary page 7.
- K161244: s-Clean OneQ-SL Narrow Implant System, Dentis Co., Ltd. (2016) Summary page 7.
- K150344: Dentis Dental Implant System, Dentis Co., Ltd. (2015) Summary page 17.

## Most influential descendants
- K171694: s-Clean TiN Coating Abutments (2017), 2 descendants of its own
- K252286: BIORES Dental Implant System (2026), 0 descendants of its own
- K230126: Dentis s-Clean Regular Abutment (2023), 0 descendants of its own
- K220440: Dentis s-Clean Abutment Mini (2022), 0 descendants of its own
- K210080: Dentis s-Clean s-Line Mini (2021), 0 descendants of its own

## Indications for use
The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient’s chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for inmediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K171027
Methodology: https://510kreport.com/methodology