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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 K122664
Device Name ZUGA DENTAL IMPLANT SYSTEM
Applicant
ZUGA MEDICAL, INC.
p.o. box 566
chesterland,  OH  44026 2141
Contact karen e warden, phd
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/31/2012
Decision Date 04/30/2013
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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