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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K890464
Device Name ZENITH 40% PHOSPHORIC ACID GEL
Applicant
Foremost Dental Mfg., Inc.
242 S. Dean St.
Englewood,  NJ  07631
Applicant Contact TIM WOLF
Correspondent
Foremost Dental Mfg., Inc.
242 S. Dean St.
Englewood,  NJ  07631
Correspondent Contact TIM WOLF
Regulation Number872.3765
Classification Product Code
EBC  
Date Received01/30/1989
Decision Date 02/13/1989
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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