# K024004: Xive Transgingival Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Friadent GmbH
- Decided: Mar 3, 2003 after 89 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: 4 generations back to K894595 (1990). 14 ancestors in all.
425 later devices descend from it; 5 cite it directly.
0 of 440 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013067: Frialoc Dental Implant System, Friadent GmbH (2002)
- K013867: Xive Dental Implant System, Friadent GmbH (2002)

## Most influential descendants
- K032284: Xive TG Dental Implant System (2003), 394 descendants of its own
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own
- K053088: Slactive Implants (2006), 295 descendants of its own
- K083550: Straumann Dental Implant System (2009), 228 descendants of its own
- K060958: Straumann Narrow Neck Implants (2006), 228 descendants of its own

## Indications for use
The XiVE@Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants 2 9.5mm 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/K024004
Methodology: https://510kreport.com/methodology