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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 K082200
Device Name KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
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 Number872.3640
Classification Product Code
DZE  
Date Received08/04/2008
Decision Date 11/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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