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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K252110
Device Name Dental X-RAY Unit (AJX200)
Applicant
Guangzhou Ajax Medical Equipment Co., Ltd.
Bldg. #2, Dagang Industrial Zone
Shilou Town, Panyu District
Guangzhou,  CN 511447
Applicant Contact Sophia Xu
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
198 Kezhu Rd., Scientech Park Guangzhou Economic &
Technology Development District, Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Jett Lee
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/07/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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