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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 K871562
Device Name IONOCAL
Applicant
Foremost Dental Mfg., Inc.
242 S. Dean St.
Englewood,  NJ  07631
Applicant Contact WOLF
Correspondent
Foremost Dental Mfg., Inc.
242 S. Dean St.
Englewood,  NJ  07631
Correspondent Contact WOLF
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/22/1987
Decision Date 05/20/1987
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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