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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 K182081
Device Name JDentalCare Implant System JDIcon
Applicant
J Dental Care S.r.l.
via del Tirassengno 41/N
modena,  IT 41122
Applicant Contact giacomo grandi
Correspondent
Isemed Srl
Via Palmiro Togliatti 19/X
imola,  IT 40026
Correspondent Contact guido gonapace
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/02/2018
Decision Date 06/26/2020
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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