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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 K080224
Device Name KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
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 Received01/29/2008
Decision Date 07/03/2008
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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