# K052957: Implantium Prosthetics

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Jul 27, 2006 after 279 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: 1 generation back to K931767 (1994). 2 ancestors in all.
78 later devices descend from it; 10 cite it directly.
0 of 81 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.
- K931767: Astra Tech Implants-Dental System, Astra Tech, Inc. (1994) Summary page 1.

## Most influential descendants
- K070228: Implantium Prosthetics (2007), 63 descendants of its own
- K112045: Simpleline II Abutment System (2012), 60 descendants of its own
- K121843: NP-Cast Abutment System (2012), 54 descendants of its own
- K140507: Hiossen Prosthetic System (2014), 44 descendants of its own
- K160670: ET US SS Prosthetic system (2017), 32 descendants of its own

## Indications for use
Implantium Prosthetics is intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K052957
Methodology: https://510kreport.com/methodology