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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 K113738
Device Name CREODENT SOLIDEX CUSTOM ABUTMENT
Original Applicant
CREODENT PROSTHETICS LTD.
29th west street
11th floor
new york,  NY  10001
Original Contact calvin shim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/20/2011
Decision Date 09/17/2013
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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