# K222946: Oneday Mini Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Oneday Biotech Co., Ltd.
- Decided: Aug 23, 2023 after 330 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: 4 generations back to K041368 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161987: UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - Suprastructure, Dio Corporation (2017) Summary page 4.
- K182194: UV Active Implant System, Dio Corporation (2018) Summary page 9.

## Indications for use
The Oneday Mini 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 Oneday Mini 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/K222946
Methodology: https://510kreport.com/methodology