# K251148: JDEvolution Plus L and JDEvolution Plus LE

- Pathway: 510(k) (Traditional)
- Applicant: Jdentalcare Srl
- Decided: Sep 25, 2025 after 164 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: 10 generations back to K925765 (1993). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160119: NobelSpeedy Groovy, Nobel Biocare AB (2016) Summary page 6.

## Indications for use
JDEvolution Plus L and JDEvolution Plus LE implant system is intended for surgical placement in the upper jaw. JDEvolution Plus L and JDEvolution Plus LE implant system provides a means for prosthetic attachment in partially or fully edentulous spans with multiple teeth utilizing delayed, or immediate loading, or as a terminal or intermediary abutment for fixed ore removable bridgework or to retain overdentures. JDEvolution Plus L and JDEvolution Plus LE is intended for immediate function multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. JDEvolution Plus L and JDEvolution Plus LE implants with lengths of 18, 20, 22, 24, 26 mm are only indicated for multiple unit restorations in splinted applications with at least two implants when placed in the maxilla.

Source page: https://510kreport.com/device/K251148
Methodology: https://510kreport.com/methodology