# K082843: Modificaton to: Dentis Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Jun 19, 2009 after 263 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 K894595 (1990). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073465: US/GS Ultra Wide System, Osstem Implant Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K230126: Dentis s-Clean Regular Abutment (2023), 0 descendants of its own

## Indications for use
The Dentis Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. including; cemented retained, screw retained, or overdenture restorations, and terminal or. intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not for immediate load. Also, this system is intended to be used in the molar region.

Source page: https://510kreport.com/device/K082843
Methodology: https://510kreport.com/methodology