# K191634: Scan Abutments and Comfort Caps

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Nov 4, 2019 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: 2 generations back to K925780 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172640: Dentium Implantium & SuperLine Prosthetics, Dentium Co., Ltd. (2018) Summary page 4.
- K153268: NR Line Implant System, Dentium Co., Ltd. (2016) Summary page 4.
- K171142: Healing Cap Multi-Unit Titanium, Nobel Biocare AB (2017) Summary page 4.

## Indications for use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K191634
Methodology: https://510kreport.com/methodology