Dental X-RAY Unit (AJX200)— 510(k) K252110

Name: FDA 510(k) clearance K252110
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Guangzhou Ajax Medical Equipment Co., Ltd.

FDA 510(k) clearance K252110 for Dental X-RAY Unit (AJX200), Substantially Equivalent on 2026-03-12. Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Ajax Medical Equipment Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2025-07-07
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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