Surefil One Self-adhesive Composite Hybrid

Cement, Dental

Dentsply Sirona

The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Surefil One Self-adhesive Composite Hybrid.

Pre-market Notification Details

Device IDK192530
510k NumberK192530
Device Name:Surefil One Self-adhesive Composite Hybrid
ClassificationCement, Dental
Applicant Dentsply Sirona 221 W Philadelphia Street, Suite 60W York,  PA  17401
ContactKarl Nittinger
CorrespondentKarl Nittinger
Dentsply Sirona 221 W Philadelphia Street, Suite 60W York,  PA  17401
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-16
Decision Date2020-01-23

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