Helioseal F Plus

Sealant, Pit And Fissure, And Conditioner

Ivoclar Vivadent, AG

The following data is part of a premarket notification filed by Ivoclar Vivadent, Ag with the FDA for Helioseal F Plus.

Pre-market Notification Details

Device IDK190339
510k NumberK190339
Device Name:Helioseal F Plus
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant Ivoclar Vivadent, AG Bendererstrasse 2 Schaan,  LI Fl-9494
ContactSandra Cakebread
CorrespondentLori Aleshin
Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst,  NY  14228
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-14
Decision Date2019-07-29
Summary:summary

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