# K190849: IS-III active System_S-narrow Type

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Aug 14, 2019 after 135 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: 13 generations back to K960026 (1996). 109 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130462: Paltop Narrow Implant, Paltop Short Implant, Paltop Advanced Dental Solutions, Ltd. (2013) Summary page 4.
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K240091: NB Mini Implant System (2024), 0 descendants of its own

## Indications for use
The IS-III active System_S-narrow Type 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 IS-III active System_S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K190849
Methodology: https://510kreport.com/methodology