# K143142: JDENTALCARE Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jdentalcare Srl
- Decided: Nov 6, 2015 after 368 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: 8 generations back to K894595 (1990). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 5.

## Most influential descendants
- K182081: JDentalCare Implant System JDIcon (2020), 1 descendant of its own
- K233896: JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus (2024), 0 descendants of its own

## Indications for use
JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices. JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability 1s achieved, with appropriate occlusal loading, in order to restore chewing function.

Source page: https://510kreport.com/device/K143142
Methodology: https://510kreport.com/methodology