# K231411: INNO SLA Submerged Hybrid Ti-Base System

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Dec 20, 2023 after 218 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: 18 generations back to K960026 (1996). 432 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 434 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200817: URIS OMNI Narrow System & Prosthetic, Truabutment, Inc. (2020) Summary page 5.

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

## Indications for use
INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi validated milling center for manufacture.

Source page: https://510kreport.com/device/K231411
Methodology: https://510kreport.com/methodology