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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 K040757
Device Name SIC PRO
Applicant
Sic Invent AG
Ch-4055
Basel,  CH
Applicant Contact GEORG SCHILLI
Correspondent
Sic Invent AG
Ch-4055
Basel,  CH
Correspondent Contact GEORG SCHILLI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/25/2004
Decision Date 04/13/2005
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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