# K081748: Oneplant Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Warantec Co., Ltd.
- Decided: Mar 27, 2009 after 281 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). 59 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070228: Implantium Prosthetics, Dentium Co., Ltd. (2007) Summary page 1.
- K052957: Implantium Prosthetics, Dentium Co., Ltd. (2006) Summary page 1.
- K060501: Implantium II, Dentium Co., Ltd. (2006) Summary page 1.
- K052823: Implantium Abutments, Dentium, Inc. (2006) Summary page 1.
- K041368: Dentium CO., LTD. Implantium, Dentium Co., Ltd. (2004) Summary page 1.
- K051576: Avana Dental Implant System, Osstem Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K172100: URIS OMNI System (2018), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K231411: INNO SLA Submerged Hybrid Ti-Base System (2023), 1 descendant of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own

## Indications for use
ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework..

Source page: https://510kreport.com/device/K081748
Methodology: https://510kreport.com/methodology