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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
Applicant
THE YOSHIDA DENTAL MFG. CO., LTD.
1-14-1 kandasuda-cho
funai tokyo technology ctr bldg 10f
chiyoda-ku, tokyo, 
Contact toshimitsu murakami
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/24/2012
Decision Date 04/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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