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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 K061500
Device Name SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
Applicant
Sic Invent AG
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Applicant Contact FRANZ MENEAN
Correspondent
Sic Invent AG
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact FRANZ MENEAN
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/31/2006
Decision Date 08/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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