# K153268: NR Line Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Jul 20, 2016 after 251 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K191634: Scan Abutments and Comfort Caps (2019), 0 descendants of its own

## Indications for use
The NR Line Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient’s chewing function. NR Line Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K153268
Methodology: https://510kreport.com/methodology