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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K122199
Device Name PREXION3D ECLIPSE
Original Applicant
THE YOSHIDA DENTAL MFG. CO., LTD.
1-14-1 kandasuda-cho
funai tokyo technology ctr bldg 10f
chiyoda-ku, tokyo,  JP 101-0041
Original Contact toshimitsu murakami
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/24/2012
Decision Date 04/18/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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