# K210903: IS Multi Unit Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Neobiotech Co., Ltd.
- Decided: Jul 23, 2021 after 119 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K894595 (1990). 68 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own

## Indications for use
IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.

Source page: https://510kreport.com/device/K210903
Methodology: https://510kreport.com/methodology