# K191201: EM SA Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Nov 15, 2019 after 193 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: 13 generations back to K960026 (1996). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122171: MS SA Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K242379: LL Implant System (2024), 0 descendants of its own

## Indications for use
The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only. The EM SA Implant (NARROW RIDGE) 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/K191201
Methodology: https://510kreport.com/methodology