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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 K890608
Device Name FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT
Applicant
Macrochem Corp.
9 Linnell Cir.
Billerica,  MA  01820
Applicant Contact WOLTER, M.D.
Correspondent
Macrochem Corp.
9 Linnell Cir.
Billerica,  MA  01820
Correspondent Contact WOLTER, M.D.
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/06/1989
Decision Date 04/17/1989
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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