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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 K010132
Device Name KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
Applicant
SOADCO, S.L.
Av Fiter I Rossell
4 Bis Local 2
Escaldes-Engordany,  AD AD-700
Applicant Contact MERCEDES ROLDAN
Correspondent
SOADCO, S.L.
Av Fiter I Rossell
4 Bis Local 2
Escaldes-Engordany,  AD AD-700
Correspondent Contact MERCEDES ROLDAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/16/2001
Decision Date 06/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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