# K231395: INNO SLA Submerged Narrow Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Oct 18, 2023 after 156 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: 18 generations back to K960026 (1996). 457 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 459 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 5.
- K162890: BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment, Straumann USA, LLC (2017) Summary page 5.
- K132242: Inno Sla Submerged Implant System, Cowellmedi Co., Ltd. (2013) Summary page 5.
- K201323: INNO SLA Submerged Implant System, Cowellmedi Co., Ltd. (2022) Summary page 6.
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 6.
- K210117: Paltop Narrow Implant, Paltop Advanced Dental Solutions, Ltd. (2021) Summary page 6.
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 13.
- K160965: SuperLine, Dentium Co., Ltd. (2017) Summary page 6.
- K081748: Oneplant Dental Implant System, Warantec Co., Ltd. (2009) Summary page 6.
- K200817: URIS OMNI Narrow System & Prosthetic, Truabutment, Inc. (2020) Summary page 6.
- K201981: Magicore System, Innobiosurg Co., Ltd. (2020) Summary page 6.
- K210903: IS Multi Unit Abutment System, Neobiotech Co., Ltd. (2021) Summary page 6.

## Most influential descendants
- K251605: DIMPLO Implant System (2025), 0 descendants of its own

## Indications for use
INNO SLA Submerged 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 3.3mm, 3.5mm diameter INNO Sub 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/K231395
Methodology: https://510kreport.com/methodology