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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 K121873
Device Name AVINENT DENTAL IMPLANT SYSTEM
Applicant
Avinent Implant System S.L.
Pol. Ind. Santa Anna
Apartat 20
Santpedor,  ES 08251
Applicant Contact ANNA CORTINA
Correspondent
Avinent Implant System S.L.
Pol. Ind. Santa Anna
Apartat 20
Santpedor,  ES 08251
Correspondent Contact ANNA CORTINA
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/27/2012
Decision Date 12/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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