# K170384: Dentium NR Line CAD/CAM Abutments

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium Co., Ltd.
- Decided: Aug 17, 2017 after 191 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Source page: https://510kreport.com/device/K170384
Methodology: https://510kreport.com/methodology