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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K151194
Device Name KLOCKNER DENTAL IMPLANT ABUTMENTS (II)
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 Number872.3630
Classification Product Code
NHA  
Date Received05/04/2015
Decision Date 01/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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