# K030639: Xive 3.0 Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Friandent GmbH
- Decided: Aug 12, 2003 after 165 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: 2 generations back to K925765 (1993). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994376: Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA, Friadent GmbH (2000) Summary page 1.

## Most influential descendants
- K050970: Milo Dental Implant System (2005), 7 descendants of its own
- K131701: Z5MLB, Z5MLC (2013), 1 descendant of its own
- K130140: Intra-Lock OP Dental Implant (2013), 1 descendant of its own
- K121707: Lew Mdi O-Ball Collared Implant, (2012), 1 descendant of its own
- K200386: Z5-BL (2020), 0 descendants of its own

## 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/K030639
Methodology: https://510kreport.com/methodology