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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 K082573
Device Name SARGON NON-EXPANDABLE DENTAL IMPLANT
Original Applicant
SARGON ENT., INC.
5335 wisconsin ave. nw
suite 440
washington,  DC  20015
Original Contact daniel j manelli
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/05/2008
Decision Date 07/21/2010
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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