# K161987: UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - Suprastructure

- Pathway: 510(k) (Traditional)
- Applicant: Dio Corporation
- Decided: Feb 21, 2017 after 217 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
- K222946: Oneday Mini Implant System (2023), 0 descendants of its own

## Indications for use
The UF(II) Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0mm, 3.3mm diameter UF(II) Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.

Source page: https://510kreport.com/device/K161987
Methodology: https://510kreport.com/methodology