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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K982191
Device Name CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
Applicant
Medental Intl.
1246 Clear Creek Rd.
Evergreen,  CO  80434
Applicant Contact DEBRA OLSON
Correspondent
Medental Intl.
1246 Clear Creek Rd.
Evergreen,  CO  80434
Correspondent Contact DEBRA OLSON
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/22/1998
Decision Date 09/14/1998
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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