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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name liner, cavity, calcium hydroxide
510(k) Number K926419
Device Name CALCICUR
Original Applicant
c/o medical device resources
7527 westmoreland avenue
st. louis,  MO  63105
Original Contact evan g dick
Regulation Number872.3250
Classification Product Code
Date Received12/23/1992
Decision Date 03/31/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No