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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 K845034
Device Name FOREMOST LITE CURE PIT & FISSURE SEALANT
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 Received12/27/1984
Decision Date 03/18/1985
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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