# K181138: IS-III active System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Oct 3, 2018 after 156 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: 10 generations back to K894595 (1990). 26 ancestors in all.
23 later devices descend from it; 11 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113554: Cmi Implant IS System, Neobiotech Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K213506: NB 1 SA Implant System (2022), 5 descendants of its own
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K231426: 8plant Implant System (2024), 1 descendant of its own
- K231753: Oneday Implant Abutment (2024), 1 descendant of its own

## Indications for use
The IS-111 active System is indicated for use in partially or fully edentulous mandibles and maxillae. in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. IS-111 active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than Smm are indicated for molar regions.

Source page: https://510kreport.com/device/K181138
Methodology: https://510kreport.com/methodology