# K052823: Implantium Abutments

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium, Inc.
- Decided: Feb 21, 2006 after 140 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944964 (1995). 40 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 62 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.
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004, Nobel Biocare Uas, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K141457: Dentium Implantium and Superline Abutments (2014), 6 descendants of its own
- K221866: S-Plant Dental Implant System (2024), 2 descendants of its own

## Indications for use
The Implantium abutments are intended to be used with the Implantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.

Source page: https://510kreport.com/device/K052823
Methodology: https://510kreport.com/methodology