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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 K121334
Device Name VARIOECO
Applicant
THOMMEN MEDICAL, AG
11234 el camino real, ste. 200
san diego,  CA  92130
Contact linda k schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/03/2012
Decision Date 08/14/2012
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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