# K242379: LL Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ossvis Co., Ltd.
- Decided: Nov 7, 2024 after 87 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: 14 generations back to K960026 (1996). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191201: EM SA Implant System, Hiossen, Inc. (2019) Summary page 5.

## Indications for use
The LL Implant System is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.

Source page: https://510kreport.com/device/K242379
Methodology: https://510kreport.com/methodology