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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K102804
Device Name SPI TITANIUM BASE FOR CAD/CAM
Original Applicant
THOMMEN MEDICAL, AG
11234 el camino real,
suite 200
san diego,  CA  92130
Original Contact linda k schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/27/2010
Decision Date 04/20/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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