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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 E. 134th St.
Bronx,  NY  10454
Applicant Contact LARRY FISHMAN
Correspondent
Majestic Drug Co., Inc.
711-717 E. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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