# K081078: NT/IT System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Jul 15, 2008 after 90 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). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 1.
- K073628: Synocta Abutments, Straumann USA (2008) Summary page 1.
- K080286: Cementable Abuntments; Temporary Copings; Protective Caps, Straumann USA (2008) Summary page 1.
- K062051: SS System, Osstem Implant Co., Ltd. (2006) Summary page 1.
- K063861: GS System, Osstem Implant Co., Ltd. (2007) Summary page 1.
- K073247: US/SS/GS System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Indications for use
The NT/IT 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. The NT/IT System is for single and two stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K081078
Methodology: https://510kreport.com/methodology