# K234112: Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: May 9, 2024 after 134 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: 18 generations back to K894844 (1990). 175 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223634: Customized Abutment, Arum Dentistry Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K242768: Customized Abutment and Screw (2025), 0 descendants of its own

## Indications for use
The 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 abutment screw. Patient-Specific Abutment is compatible with following Implant Systems: 1. Zimmer Tapered Screw-Vent® / Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7 2. Straumann® Bone Level Tapered Implant / Implant diameter size (mm): 3.3, 4.1, 4.8/ Restorative Platform diameter (mm): 3.1, 3.7, 4.4 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/K234112
Methodology: https://510kreport.com/methodology