# K151375: Inclusive Titanium Abutments compatible with: Hiossen HG Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Oct 7, 2015 after 138 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: 7 generations back to K925765 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100993: Inclusive Titanium Abutments for Astra Tech Osseospeed Implants, Prismatik Dentalcraft, Inc. (2010) Summary page 5.

## Indications for use
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K151375
Methodology: https://510kreport.com/methodology