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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 K875091
Device Name ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT
Applicant
Mission White Dental, Inc.
31 Park Rd.
Tinton Falls,  NJ  07724
Applicant Contact JOSEPH J BUTLER
Correspondent
Mission White Dental, Inc.
31 Park Rd.
Tinton Falls,  NJ  07724
Correspondent Contact JOSEPH J BUTLER
Regulation Number872.3765
Classification Product Code
EBC  
Date Received12/10/1987
Decision Date 02/29/1988
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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