# K240143: JDZygoma dental implants

- Pathway: 510(k) (Traditional)
- Applicant: Jdentalcare Srl
- Decided: Oct 11, 2024 after 267 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: 17 generations back to K960026 (1996). 260 ancestors in all.
No later device cites it as a predicate yet.
0 of 261 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151909: Noris Medical Zygomatic Dental Implant System, Noris Medical, Ltd. (2016) Summary page 6.

## Indications for use
JDZygoma Dental implant is a JDentalCare implant system. JDZygoma Dental implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxilla, in order to restore patient esthetics and chewing function. The JDZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K240143
Methodology: https://510kreport.com/methodology