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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 K923895
Device Name QUIKSEAL
Applicant
Mirage Dental Systems
200 N. 6th St.
Kansas City,  KS  66101
Applicant Contact TIMOTHY J SIGLER
Correspondent
Mirage Dental Systems
200 N. 6th St.
Kansas City,  KS  66101
Correspondent Contact TIMOTHY J SIGLER
Regulation Number872.3765
Classification Product Code
EBC  
Date Received08/04/1992
Decision Date 12/23/1992
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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