# K032750: Modification to: Xive 3.0 Dental Implant System, Multiple

- Pathway: 510(k) (Special)
- Applicant: Friandent GmbH
- Decided: Oct 2, 2003 after 27 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925765 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030639: Xive 3.0 Dental Implant System, Friandent GmbH (2003)

## Recalls of this device
- Nov 17, 2006 · Not classified · Z-0230-2007: Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
- Nov 17, 2006 · Not classified · Z-0231-2007: Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
- Nov 17, 2006 · Not classified · Z-0232-2007: Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.

## Indications for use
The XiVE@3.0 Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.

Source page: https://510kreport.com/device/K032750
Methodology: https://510kreport.com/methodology