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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 K802562
Device Name PRISMA SEAL
Applicant
Dentsply Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dentsply Intl.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3765
Classification Product Code
EBC  
Date Received10/16/1980
Decision Date 11/12/1980
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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