# K013867: Xive Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Mar 15, 2002 after 114 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
No predicates in its family tree.
570 later devices descend from it; 6 cite it directly.
0 of 571 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K925765: Branemark System Standard 3.75MM Fixture, Nobelpharma USA, Inc. (1993). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K934584: Spectrolyse Factor Vii:C, Meditech, Inc. (1993). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K021318: Xive Dental Implant System (2002), 547 descendants of its own
- K032158: Xive Dental Implant System Multiple (2003), 542 descendants of its own
- K024004: Xive Transgingival Dental Implant System (2003), 425 descendants of its own
- K032284: Xive TG Dental Implant System (2003), 394 descendants of its own
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own

## Indications for use
The XiVE Dental Implant System is indicated as follows: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations.

Source page: https://510kreport.com/device/K013867
Methodology: https://510kreport.com/methodology