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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K935032
Device Name ZENITH TOTAL ETCH 10% PHOSPHORIC ACID
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 Number872.3690
Classification Product Code
EBF  
Date Received10/20/1993
Decision Date 01/18/1994
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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