# K113554: Cmi Implant IS System

- Pathway: 510(k) (Special)
- Applicant: Neobiotech Co., Ltd.
- Decided: Apr 5, 2012 after 126 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: 9 generations back to K894595 (1990). 25 ancestors in all.
34 later devices descend from it; 4 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090825: SQ IS System, Neobiotech Co., Ltd. (2009) Summary page 3.

## Most influential descendants
- K181138: IS-III active System (2018), 23 descendants of its own
- K120503: Cmi Implant IS II Active (2012), 9 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K172100: URIS OMNI System (2018), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own

## Indications for use
The CMI Implant IS 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 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 5 mm are indicated for molar regions.

Source page: https://510kreport.com/device/K113554
Methodology: https://510kreport.com/methodology