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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K901870
Device Name DEGUFILL (R) BOND
Applicant
Degussa AG
Postfach 110533
D-6000 Frankfurt 11
West Germany,  DE
Applicant Contact MACKERT
Correspondent
Degussa AG
Postfach 110533
D-6000 Frankfurt 11
West Germany,  DE
Correspondent Contact MACKERT
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/24/1990
Decision Date 08/06/1990
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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