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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 K071240
Device Name IMPLASA-HOECHST GMBH IMPLANTS
Applicant
Implasa-Hoechst GmbH
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
Implasa-Hoechst GmbH
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received05/03/2007
Decision Date 01/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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