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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 K113376
Device Name NEOSS PROACTIVE TAPERED IMPLANT
Applicant
NEOSS LTD
901 king street
suite 200
alexandria,  VA  22314
Contact cherita james
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/16/2011
Decision Date 09/05/2012
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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