EDS Bioceramic Sealer (Bioseal)

Resin, Root Canal Filling

Essential Dental Systems

The following data is part of a premarket notification filed by Essential Dental Systems with the FDA for Eds Bioceramic Sealer (bioseal).

Pre-market Notification Details

Device IDK202281
510k NumberK202281
Device Name:EDS Bioceramic Sealer (Bioseal)
ClassificationResin, Root Canal Filling
Applicant Essential Dental Systems 89 Leuning Street South Hackensack,  NJ  07606
ContactJason Guzman
CorrespondentJason Guzman
Essential Dental Systems 89 Leuning Street South Hackensack,  NJ  07606
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-12
Decision Date2021-02-12

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