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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K861546
Device Name REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
Applicant
Macrochem Corp.
21x Olympia Ave.
Woburn,  MA  01801
Applicant Contact JAMES R MARSHALL
Correspondent
Macrochem Corp.
21x Olympia Ave.
Woburn,  MA  01801
Correspondent Contact JAMES R MARSHALL
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/25/1986
Decision Date 05/21/1986
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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