# K171622: Dentium Ti-Base

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Jan 11, 2018 after 223 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: 15 generations back to K960026 (1996). 255 ancestors in all.
No later device cites it as a predicate yet.
0 of 256 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150367: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 4.
- K161713: Dentium CAD/CAM Abutments, Dentium Co., Ltd. (2016) Summary page 4.

## Indications for use
Dentium Ti-Base abutments are intended for use on Dentium 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 Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Source page: https://510kreport.com/device/K171622
Methodology: https://510kreport.com/methodology