# K161713: Dentium CAD/CAM Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Dec 16, 2016 after 178 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: 14 generations back to K894844 (1990). 202 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 5.
- K103020: Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment, Atlantis Components, Inc. (2011) Summary page 5.

## Most influential descendants
- K251605: DIMPLO Implant System (2025), 0 descendants of its own
- K221972: Warantec Custom Abutment (2023), 0 descendants of its own
- K171622: Dentium Ti-Base (2018), 0 descendants of its own

## 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/K161713
Methodology: https://510kreport.com/methodology