# K191751: EM Provisional

- Pathway: 510(k) (Abbreviated)
- Applicant: Hiossen, Inc.
- Decided: Dec 16, 2019 after 168 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: 1 generation back to K072871 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072871: MS System (Provisional), Osstem Implant Co., Ltd. (2008) Summary page 4.

## Most influential descendants
- K200573: BoneTrust Mini Implant System (2021), 0 descendants of its own

## Indications for use
The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).

Source page: https://510kreport.com/device/K191751
Methodology: https://510kreport.com/methodology