VILA PC

Adhesive, Bracket And Tooth Conditioner, Resin

HEALTH-DENT INTL., INC.

The following data is part of a premarket notification filed by Health-dent Intl., Inc. with the FDA for Vila Pc.

Pre-market Notification Details

Device IDK951380
510k NumberK951380
Device Name:VILA PC
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake,  IL  60164
ContactAl Bevilacqua
CorrespondentAl Bevilacqua
HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake,  IL  60164
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-27
Decision Date1995-04-27

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