# K060501: Implantium II

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium Co., Ltd.
- Decided: Jun 16, 2006 after 112 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: 1 generation back to K041368 (2004). 1 ancestor in all.
26 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041368: Dentium CO., LTD. Implantium, Dentium Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K122519: Dio UF Hsa Internal Sub-Merged Implant System (2013), 12 descendants of its own
- K081748: Oneplant Dental Implant System (2009), 9 descendants of its own
- K172100: URIS OMNI System (2018), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K170608: UF (II) Implant System (2018), 4 descendants of its own

## Indications for use
Implantium II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. Implantium II are for single stage or two stage surgery.

Source page: https://510kreport.com/device/K060501
Methodology: https://510kreport.com/methodology