# K123627: ET Smartfit Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Jun 28, 2013 after 217 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: 11 generations back to K894595 (1990). 28 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110308: Prosthetic System, Osstem Implant Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K152559: TruAbutment DS (2016), 18 descendants of its own
- K170259: TruAbutment DS (2017), 17 descendants of its own
- K172304: TruAbutment DS (2018), 8 descendants of its own
- K183106: TruAbutment DS (2020), 7 descendants of its own
- K201197: TruAbutment DS, TruBase S (2021), 6 descendants of its own

## Indications for use
ET SMARTfit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Source page: https://510kreport.com/device/K123627
Methodology: https://510kreport.com/methodology