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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K930455
Device Name CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER
Applicant
Voco GmbH
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN G DICK
Correspondent
Voco GmbH
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN G DICK
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/27/1993
Decision Date 04/08/1993
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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