# K041368: Dentium CO., LTD. Implantium

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium Co., Ltd.
- Decided: Jul 29, 2004 after 66 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
98 later devices descend from it; 10 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K012965: Astra Tech Implants-Dental System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K052957: Implantium Prosthetics (2006), 78 descendants of its own
- 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

## Recalls of this device
- Jun 29, 2007 · Not classified · Z-1119-2007: Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assu

## Indications for use
The Dentium Co., Ltd Implantium is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, IIor III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

Source page: https://510kreport.com/device/K041368
Methodology: https://510kreport.com/methodology