# K073486: Dentis Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Apr 4, 2008 after 114 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: 8 generations back to K944964 (1995). 56 ancestors in all.
25 later devices descend from it; 5 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061797: SM Implant Systems, Dio Department Dsi, Inc. (2006) Summary page 2.
- K070562: EZ Plus Implant System, Megagen Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K150344: Dentis Dental Implant System (2015), 20 descendants of its own
- 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
- K160221: Implance Dental Implant System, Implance Dental Abutment System (2016), 3 descendants of its own

## Indications for use
The Dentis Dental Implant system is an endosseous dental implant that is indicated to use 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, and not indicated for single, unsplinted implants.

Source page: https://510kreport.com/device/K073486
Methodology: https://510kreport.com/methodology