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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K041680
Device Name ORAJEL ADVANCED TOOTH DESENSITIZER
Applicant
Del Pharmaceuticals, Inc.
178 Eab Plaza, Po Bx 9357
Uniondale,  NY  11553 -9357
Applicant Contact MARLENE TIETJEN
Correspondent
Del Pharmaceuticals, Inc.
178 Eab Plaza, Po Bx 9357
Uniondale,  NY  11553 -9357
Correspondent Contact MARLENE TIETJEN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/21/2004
Decision Date 11/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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