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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K933893
Device Name VISION PROPHY PASTE WITHOUT FLUORIDE
Applicant
Block Drug Company, Inc.
257 Cornelison Ave.
Jersey City,  NJ  07302
Applicant Contact ORVILLE W OSTMANN
Correspondent
Block Drug Company, Inc.
257 Cornelison Ave.
Jersey City,  NJ  07302
Correspondent Contact ORVILLE W OSTMANN
Regulation Number872.6030
Classification Product Code
EJR  
Date Received08/10/1993
Decision Date 11/16/1993
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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