Customized Abutment and Screw— 510(k) K242768

Substantially Equivalent

Chengdu Besmile Medical Technology Co., Ltd.

FDA 510(k) clearance K242768 for Customized Abutment and Screw, Substantially Equivalent on 2025-09-02. Applicant: Chengdu Besmile Medical Technology Co., Ltd..

Clearance details

Applicant: Chengdu Besmile Medical Technology Co., Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2024-09-13
Decision date: 2025-09-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chengdu, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.