# K241127: INNO SLA Mini Plus® Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cowellmedi Co., Ltd.
- Decided: Dec 27, 2024 after 248 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: 12 generations back to K960026 (1996). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112540: S-Mini Implant System, Neobiotech Co., Ltd. (2012) Summary page 5.
- K083067: MS System, Osstem Implant Co., Ltd. (2009) Summary page 5.

## Indications for use
The INNO SLA Mini Plus® Implant System is divided into two types: - Cemented Type The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients. - Ball Type The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exceed one hundred and eighty (180) days. The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K241127
Methodology: https://510kreport.com/methodology