# K040170: Friadent Plus Dental Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Friadent GmbH
- Decided: Oct 27, 2004 after 275 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: 6 generations back to K894595 (1990). 26 ancestors in all.
84 later devices descend from it; 1 cites it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031674: Modification to Frialit-2 Dental Implant System, Friadent GmbH (2003). Our reading of the summary gave K031671, FDA’s number for Polaris WR (Syneron Medical, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FRIALIT® Dental Implant System”.
- K032158: Xive Dental Implant System Multiple, Friadent GmbH (2003) Summary page 1.
- K032284: Xive TG Dental Implant System, Friadent GmbH (2003) Summary page 1.
- K032302: Xive TG Abutments, Friadent GmbH (2003) Summary page 1.

## Most influential descendants
- K102804: Spi Titanium Base for Cad/Cam (2011), 83 descendants of its own
- K103691: Biohorizons Abutments for Zimmer (2011), 45 descendants of its own
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare (2011), 30 descendants of its own
- K122295: Core 3D Abutment System for Digital Prosthetic Solutions (2013), 29 descendants of its own

## Indications for use
The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement. The XiVE® PLUS 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 (>1 1mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement. The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 and 10 and 23 to 26. The XiVE® TG PLUS 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 (>1lmm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement. FRIADENT PLUS grit-blasted and high temperature acid-etched implants display higher removal torque values compared to solely acid-etched implants and anodic oxidized textured implants. The high removal torque values of FRIADENT PLUS implants after a loading period of 5 months may be interpreted as an increase in the strength of endosseous implant integration and implant stability.

Source page: https://510kreport.com/device/K040170
Methodology: https://510kreport.com/methodology