# K223634: Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Apr 28, 2023 after 144 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: 17 generations back to K894844 (1990). 174 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193425: Pre-Milled Blank, Arum Dentistry Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K234112: Customized Abutment (2024), 1 descendant of its own
- K242768: Customized Abutment and Screw (2025), 0 descendants of its own
- K242245: Customized Abutment (2024), 0 descendants of its own

## Indications for use
ARUM Dentistry’s Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw. Customized Abutments are compatible with the implant systems listed in the Compatibility Table: Implant Platform Restorative Platform compatibility diameter (mm) NB1SAlmplant | 54 4 4550 55,60,65 | 38 4.0, 4.15, 425, 45,50 System Implant Body diameter (mm) All digitally-designed Customized Abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.

Source page: https://510kreport.com/device/K223634
Methodology: https://510kreport.com/methodology