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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K901552
Device Name (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
Applicant
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact RONALD DUDEK
Correspondent
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact RONALD DUDEK
Regulation Number872.3710
Classification Product Code
EJH  
Date Received04/03/1990
Decision Date 06/24/1991
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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