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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 K963979
Device Name ULTRADENT UNIVERSAL DENTIN SEALANT
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Applicant Contact DAN E FISCHER
Correspondent
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Correspondent Contact DAN E FISCHER
Regulation Number872.3260
Classification Product Code
LBH  
Date Received10/03/1996
Decision Date 12/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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