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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 K122988
Device Name KLOCKNER DENTAL IMPLANT ABUTMENTS
Applicant
SOADCO, S.L.
AV FITER I ROSSELL
4 BIS LOCAL 2
escaldes-engordany,  AD ad-700
Applicant Contact maria mitjaneta
Correspondent
SOADCO, S.L.
AV FITER I ROSSELL
4 BIS LOCAL 2
escaldes-engordany,  AD ad-700
Correspondent Contact maria mitjaneta
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/26/2012
Decision Date 07/19/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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