# K032284: Xive TG Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Friadent GmbH
- Decided: Aug 14, 2003 after 21 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.
394 later devices descend from it; 3 cite it directly.
0 of 410 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024004: Xive Transgingival Dental Implant System, Friadent GmbH (2003)

## Most influential descendants
- 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
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System (2011), 222 descendants of its own

## Indications for use
The XiVE TG 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 (19Smm 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/K032284
Methodology: https://510kreport.com/methodology