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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K120875
Device Name B&W DENTAL IMPLANT SYSTEM
Original Applicant
B&W SRL
corrientes 3859
buenos aires,  AR ar
Original Contact priya bhutani
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/22/2012
Decision Date 09/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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