# K161743: Etgar Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Etgar Medical Instruments, Ltd.
- Decided: Apr 14, 2017 after 294 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intended to replace one or more missing teeth in the upper or lower jaw in partially or fully edentulous patients in order to restore chewing function. Intended to support single or multiple tooth prostheses. The prostheses can be screwed or cement retained to the abutment. Intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K161743
Methodology: https://510kreport.com/methodology