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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 K862284
Device Name SEALITE
Applicant
Sybron Corp.
C/O Nixon,Hargrave,Devans &
Doyle, Suite 800, 1 Thomas Cir.
Washington,  DC  20005
Applicant Contact KURZMAN, PC
Correspondent
Sybron Corp.
C/O Nixon,Hargrave,Devans &
Doyle, Suite 800, 1 Thomas Cir.
Washington,  DC  20005
Correspondent Contact KURZMAN, PC
Regulation Number872.3765
Classification Product Code
EBC  
Date Received06/16/1986
Decision Date 06/23/1986
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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