# K242768: Customized Abutment and Screw

- Pathway: 510(k) (Abbreviated)
- Applicant: Chengdu Besmile Medical Technology Co., Ltd.
- Decided: Sep 2, 2025 after 354 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: 19 generations back to K894844 (1990). 176 ancestors in all.
No later device cites it as a predicate yet.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234112: Customized Abutment, Arum Dentistry Co., Ltd. (2024) Summary page 5.

## Indications for use
Customized Abutment and Screw is used as a complement component for dental implants placed in the jawbone after tooth loss, to connect, support and retain the restoration or implant superstructure. Customized Abutment and Screw is indicated for single unit restorations. Customized Abutment and Screw is compatible with following Implant Systems: All digitally designed abutments for use with Customized Abutment and Screw are intended to be manufactured at a BESMILE validated milling center.

Source page: https://510kreport.com/device/K242768
Methodology: https://510kreport.com/methodology