# K241003: HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

- Pathway: 510(k) (Abbreviated)
- Applicant: Hiossen, Inc.
- Decided: Jan 8, 2025 after 271 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: 12 generations back to K894595 (1990). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123627: ET Smartfit Abutment, Hiossen, Inc. (2013) Summary page 5.

## Indications for use
The HIOSSEN Pre-milled Abutments are intended for use with HIOSSEN dental implants to provide support for prosthetic restorations such as crowns, bridges or overdentures. All digitally designed CAD/CAM customizations for the HIOSSSEN Pre-milled Abutments are intended to be sent to a HIOSSEN validated milling facility. ET HIOSSEN Pre-milled Abutments are compatible with the following devices: 1. ETIII & ETII SA Dental Implants (Mini, Regular, (Ultra-wide Regular) - K140934 / Implant Diameter (mm):3.5, 3.75, 3.77, 4.2, 4.25, 4.45, 4.6, 4.25, 4.63, 4.65, 4.9, 5.0, 5.05, 5.08, 5.1, 5.92, 5.95, 6, 6.8 2. ETIII NH Dental Implants (Mini & Regular, Ultra-wide Regular) - K151626 /Implant Diameter (mm): 3.77, 3.75, 4.25, 4.6 4.65, 4.63, 5.05, 5.08, 5.10 3. ETIII SA D3.2 Dental Implants (Mini) - K153332 /Implant Diameter (mm): 3.2 4. ET IV SA Dental Implants (Regular & Ultra-wide)- K183242 /Implant Diameter (mm):4.4, 4.8, 5.25, 6.2 & 7.1 EK HIOSSEN Pre-milled Abutments are compatible with the following devices: 1. EKIII SA Dental Implant (Mini) & EKIII NH Dental Implants (Mini) - K203360 /Implant Diameter (mm):3.5 ~ 5.5

Source page: https://510kreport.com/device/K241003
Methodology: https://510kreport.com/methodology