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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
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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