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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 K254018
Device Name Portable Dental X-ray Device (GT-1)
Applicant
Guilin Refine Medical Instrument Co., Ltd.
# 8-3, Information Industrial Park, High-Tech Zone
Qixing District
Guangxi,  CN 541004
Applicant Contact Su Qin
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/15/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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