PQ1

Agent, Tooth Bonding, Resin

ULTRADENT PRODUCTS, INC.

The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Pq1.

Pre-market Notification Details

Device IDK000189
510k NumberK000189
Device Name:PQ1
ClassificationAgent, Tooth Bonding, Resin
Applicant ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan,  UT  84095
ContactScott E Moore
CorrespondentScott E Moore
ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan,  UT  84095
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-21
Decision Date2000-05-11

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