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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K260662
Device Name Dental Cone Beam Computed Tomography System
Applicant
Yofo Medical Technology Co., Ltd.
Bldg. A1, National Health Industrial Park, Hi-Tech Industria
Hefei,  CN 230000
Applicant Contact Li Zhao
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz., W. Guangzhong Rd. 555,
Shanghai,  CN
Correspondent Contact Kyra Kang
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/02/2026
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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