# K201323: INNO SLA Submerged Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Jan 25, 2022 after 617 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: 11 generations back to K894595 (1990). 30 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132242: Inno Sla Submerged Implant System, Cowellmedi Co., Ltd. (2013) Summary page 4.
- K072878: Modification to: Locator Implant Anchor, Zest Anchors, Inc. (2007) 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
The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Source page: https://510kreport.com/device/K201323
Methodology: https://510kreport.com/methodology