# K032158: Xive Dental Implant System Multiple

- Pathway: 510(k) (Special)
- Applicant: Friadent GmbH
- Decided: Aug 14, 2003 after 30 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: 5 generations back to K894595 (1990). 15 ancestors in all.
542 later devices descend from it; 6 cite it directly.
0 of 558 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013867: Xive Dental Implant System, Friadent GmbH (2002) Summary page 1.
- K021318: Xive Dental Implant System, Friadent GmbH (2002) Summary page 1.

## Most influential descendants
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own
- K041509: Ankylos Dental Implant System (2004), 325 descendants of its own
- K053088: Slactive Implants (2006), 295 descendants of its own
- K083805: Ankylos C/X Dental Implant System (2009), 290 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own

## Indications for use
The XiVE® Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥ 9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.

Source page: https://510kreport.com/device/K032158
Methodology: https://510kreport.com/methodology