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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 K970774
Device Name TEMPOCEM NE (MULTIPLE)
Applicant
Foremost Dental Mfg., Inc.
242 - S. Dean St.
Englewood,  NJ  07631
Applicant Contact D.T. WOLF
Correspondent
Foremost Dental Mfg., Inc.
242 - S. Dean St.
Englewood,  NJ  07631
Correspondent Contact D.T. WOLF
Regulation Number872.3275
Classification Product Code
EMA  
Date Received03/04/1997
Decision Date 06/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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