ULTRACID DISINFECTING SOLOUTION

Varnish, Cavity

ULTRADENT PRODUCTS, INC.

The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Ultracid Disinfecting Soloution.

Pre-market Notification Details

Device IDK953167
510k NumberK953167
Device Name:ULTRACID DISINFECTING SOLOUTION
ClassificationVarnish, Cavity
Applicant ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan,  UT  84095
ContactL. M. Chatwin
CorrespondentL. M. Chatwin
ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan,  UT  84095
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-07
Decision Date1995-09-08

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