# K150344: Dentis Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Jul 24, 2015 after 163 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: 9 generations back to K944964 (1995). 57 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 78 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 6.

## Most influential descendants
- K153639: OneQ-SL s-Clean Implant System (2016), 14 descendants of its own
- K171027: Dentis Dental Implant System (2017), 5 descendants of its own
- K192688: s-Clean SQ-SL Implant System Regular (2020), 3 descendants of its own
- K210134: Dentis s-Clean s-Line (2021), 2 descendants of its own
- K171694: s-Clean TiN Coating Abutments (2017), 2 descendants of its own

## Indications for use
The Dentis Dental Implant System is an endosseous dental implant 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 immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted interforminal placed implants.

Source page: https://510kreport.com/device/K150344
Methodology: https://510kreport.com/methodology