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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K140056
Device Name DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A
Applicant
Rayence Co., Ltd.
8310 Buffalo Speedway
Houston,  TX  77025
Applicant Contact DAVE KIM
Correspondent
Rayence Co., Ltd.
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
MUH  
Date Received01/10/2014
Decision Date 05/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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