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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 K120414
Device Name OSSEOSPEED PLUS
Original Applicant
ASTRA TECH AB
11234 el camino real,
suite 200
san diego,  CA  92130
Original Contact linda k schulz
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/10/2012
Decision Date 07/31/2012
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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