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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 K973541
Device Name MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
Applicant
Medental Intl.
1246 Clear Creek Rd.
Evergreen,  CO  80434
Applicant Contact DEBRA GILLASPY
Correspondent
Medental Intl.
1246 Clear Creek Rd.
Evergreen,  CO  80434
Correspondent Contact DEBRA GILLASPY
Regulation Number872.3765
Classification Product Code
EBC  
Date Received09/18/1997
Decision Date 11/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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