# K251605: DIMPLO Implant System

- Pathway: 510(k) (Traditional)
- Applicant: DIMPLO, Ltd.
- Decided: Dec 22, 2025 after 209 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: 19 generations back to K960026 (1996). 481 ancestors in all.
No later device cites it as a predicate yet.
0 of 482 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 5.
- K161987: UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - Suprastructure, Dio Corporation (2017) Summary page 5.
- K141457: Dentium Implantium and Superline Abutments, Dentium Co., Ltd. (2014) Summary page 5.
- K231426: 8plant Implant System, Hoowon Edi Co., Ltd. (2024) Summary page 5.
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 5.
- K223924: LW Implant System, Ossvis Co., Ltd. (2023) Summary page 5.
- K231753: Oneday Implant Abutment, Oneday Biotech Co., Ltd. (2024) Summary page 5.
- K231411: INNO SLA Submerged Hybrid Ti-Base System, Cowellmedi Co., Ltd. (2023) Summary page 5.
- K220253: Eco Abutment, Multiunit Abutment, Dio Corporation (2023) Summary page 5.
- K210117: Paltop Narrow Implant, Paltop Advanced Dental Solutions, Ltd. (2021) Summary page 5.
- K231395: INNO SLA Submerged Narrow Implant System, Cowellmedi Co., Ltd. (2023) Summary page 5.
- K201323: INNO SLA Submerged Implant System, Cowellmedi Co., Ltd. (2022) Summary page 5.
- K161713: Dentium CAD/CAM Abutments, Dentium Co., Ltd. (2016) Summary page 5.

## Indications for use
The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved. - Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only. - Ø5.0 mm and larger implants are intended for delayed loading in the molar region. All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.

Source page: https://510kreport.com/device/K251605
Methodology: https://510kreport.com/methodology