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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 K153650
Device Name Microdent Ektos Implant System
Applicant
Implants Microdent System S.L
C/ Carles Buigas, I-Can Magre
Santa Eulalia De Roncana,  ES 08187
Applicant Contact JORDI CLAPES DONADEU
Correspondent
Implants Microdent System S.L
C/ Carles Buigas, I-Can Magre
Santa Eulalia De Roncana,  ES 08187
Correspondent Contact JORDI CLAPES DONADEU
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/21/2015
Decision Date 05/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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