ZIRCON-F PROPHYLAXIS PASTE

Agent, Polishing, Abrasive, Oral Cavity

PASCAL CO., INC.

The following data is part of a premarket notification filed by Pascal Co., Inc. with the FDA for Zircon-f Prophylaxis Paste.

Pre-market Notification Details

Device IDK040988
510k NumberK040988
Device Name:ZIRCON-F PROPHYLAXIS PASTE
ClassificationAgent, Polishing, Abrasive, Oral Cavity
Applicant PASCAL CO., INC. 2929 N.E. NORTHUP WAY Bellevue,  WA  98004
ContactVincent M Tentarelli
CorrespondentVincent M Tentarelli
PASCAL CO., INC. 2929 N.E. NORTHUP WAY Bellevue,  WA  98004
Product CodeEJR  
CFR Regulation Number872.6030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-15
Decision Date2004-07-07
Summary:summary

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