# K242245: Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Nov 25, 2024 after 117 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.
No later device cites it as a predicate yet.
0 of 176 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.

## Indications for use
The Customized Abutments are intended use 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 System: 1. Neodent Implant System -GM Line / Implant Diameter (mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0/ Restorative Platform Diameter: 3.0 2. BioHorizons Tapered Internal Implant System / Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7 3. Astra Tech Implant System / Implant Diameter (mm): 3.5, 4.0, 4.5, 5.0/ Restorative Platform Diameter: 3.5, 4.0, 4.5, 5.0 4. 3i OSSEOTITE® Certain® Dental Implants / Implant Diameter (mm): 4.1, 5.0, 6.0/ Restorative Platform Diameter: 4.1, 5.0, 6.0 All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center.

Source page: https://510kreport.com/device/K242245
Methodology: https://510kreport.com/methodology