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510(k) K153060

Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S by Rayence Co., Ltd. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2015
Date Received
October 21, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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