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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 K153098
Device Name KLOCKNER VEGA DENTAL IMPLANT SYSTEM
Applicant
Soadco, S.L.
Avgda. Fiter I Rosell., 4 Bis-Local 2
Escaldes-Engordany,  AD AD-700
Applicant Contact MARIA MITJANETA
Correspondent
Soadco, S.L.
Avgda. Fiter I Rosell., 4 Bis-Local 2
Escaldes-Engordany,  AD AD-700
Correspondent Contact MARIA MITJANETA
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/26/2015
Decision Date 04/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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