# K151757: IMMEDIATELOAD Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Immediateload S.A.
- Decided: Aug 3, 2016 after 401 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). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 4.

## Indications for use
The IMMEDIATELOAD Dental Implant System is intended to be surgically inserted into the jawbone for support and retention of dental prosthesis such as artificial teeth, crowns, bridges and overdenture to restore the aesthetics of the patient and the mastication function. The IMMEDIATELOAD dental implant system is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The UNIVERSE implants can be used for surgery in two stages or in single stage. The POWER and SOLUTION implants can be used for surgery in single stage.

Source page: https://510kreport.com/device/K151757
Methodology: https://510kreport.com/methodology