# K192436: Healing Abutments and Cover Screws

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Jan 23, 2020 after 139 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 K931767 (1994). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052957: Implantium Prosthetics, Dentium Co., Ltd. (2006) Summary page 4.

## Most influential descendants
- K210826: Healing Abutment, Cover Screw (2022), 4 descendants of its own
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K253334: ZENEX Implant System_Short (R-System) (2026), 0 descendants of its own
- K230126: Dentis s-Clean Regular Abutment (2023), 0 descendants of its own
- K230203: Dentis I-FIX Abutment (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K192436
Methodology: https://510kreport.com/methodology