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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K973919
Device Name CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
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 Number872.3260
Classification Product Code
LBH  
Date Received10/15/1997
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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