# K182081: JDentalCare Implant System JDIcon

- Pathway: 510(k) (Traditional)
- Applicant: Jdentalcare Srl
- Decided: Jun 26, 2020 after 694 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: 9 generations back to K894595 (1990). 23 ancestors in all.
1 later device descends 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)
- K143142: JDENTALCARE Implant System, Jdentalcare Srl (2015) Summary page 4.

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

## Indications for use
JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (tceth) within the maxilla or mandible. JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It 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 is achieved, with appropriate occlusal loading, in order to restore chewing function. JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied. the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Source page: https://510kreport.com/device/K182081
Methodology: https://510kreport.com/methodology