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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
Original Applicant
THOMMEN MEDICAL, AG
11234 el camino real, ste. 200
san diego,  CA  92130
Original Contact linda k schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/03/2012
Decision Date 08/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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