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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
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