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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 K964773
Device Name DENTEMP ONE STEP
Applicant
MAJESTIC DRUG CO., INC.
711-717 EAST 134TH ST.
BRONX,  NY  10454
Applicant Contact LARRY FISHMAN
Correspondent
MAJESTIC DRUG CO., INC.
711-717 EAST 134TH ST.
BRONX,  NY  10454
Correspondent Contact LARRY FISHMAN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/27/1996
Decision Date 02/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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