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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K153060
Device Name Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
Applicant
Rayence Co., Ltd.
14, Samsung 1-Ro, 1-Gil
Hwaseong-Si,  KR 445-170
Applicant Contact KEVIN KIM
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number872.1800
Classification Product Code
MUH  
Date Received10/21/2015
Decision Date 11/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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