Cleared Traditional

Dental X-RAY Unit (AJX200)

K252110 · Guangzhou Ajax Medical Equipment Co., Ltd. · Radiology

Mar 2026

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K252110 is an FDA 510(k) clearance for the Dental X-RAY Unit (AJX200), a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Guangzhou Ajax Medical Equipment Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 12, 2026, 248 days after receiving the submission on July 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K252110 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2025
Decision Date	March 12, 2026
Days to Decision	248 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF