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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 K120776
Model VARIOUS
Device Name ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION
Applicant
BIOMET 3I
4555 riverside dr.
palm bch gdns,  FL  33410
Contact tamara west
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/14/2012
Decision Date 09/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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