# K240091: NB Mini Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Apr 26, 2024 after 105 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: 16 generations back to K894595 (1990). 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)
- K190849: IS-III active System_S-narrow Type, Neobiotech Co., Ltd. (2019) Summary page 5.
- K222131: NB 1 SA Implant System, Arum Dentistry Co., Ltd. (2022) Summary page 5.
- K230725: NB Implant System, Arum Dentistry Co., Ltd. (2023) Summary page 5.
- K213506: NB 1 SA Implant System, Arum Dentistry Co., Ltd. (2022) Summary page 5.
- K232560: Angled Abutment, Arum Dentistry Co., Ltd. (2023) Summary page 5.

## Indications for use
The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini 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/K240091
Methodology: https://510kreport.com/methodology