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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 K141717
Device Name PACSEAL PIT & FISSURE SEALANT
Applicant
Pac-Dent International, Inc.
21038 Commerce Pt.e Dr.
Walnut,  CA  91789
Applicant Contact WENYING ZHU
Correspondent
Pac-Dent International, Inc.
21038 Commerce Pt.e Dr.
Walnut,  CA  91789
Correspondent Contact WENYING ZHU
Regulation Number872.3765
Classification Product Code
EBC  
Date Received06/25/2014
Decision Date 03/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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