# K172640: Dentium Implantium & SuperLine Prosthetics

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium Co., Ltd.
- Decided: May 14, 2018 after 255 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K221315: UNIdental Symphony Implant System (2023), 1 descendant of its own
- K262207: Cemented Plus Abutment (2026), 0 descendants of its own
- K191634: Scan Abutments and Comfort Caps (2019), 0 descendants of its own

## Indications for use
Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K172640
Methodology: https://510kreport.com/methodology