Plasdent Disposable Barrier Sleeves And Barrier Film

Dental Barriers And Sleeves

Plasdent Corporation

The following data is part of a premarket notification filed by Plasdent Corporation with the FDA for Plasdent Disposable Barrier Sleeves And Barrier Film.

Pre-market Notification Details

Device IDK201604
510k NumberK201604
Device Name:Plasdent Disposable Barrier Sleeves And Barrier Film
ClassificationDental Barriers And Sleeves
Applicant Plasdent Corporation 969 Price Street Pomona,  CA  91767
ContactBelen G Walayat
CorrespondentBelen G Walayat
Plasdent Corporation 969 Price Street Pomona,  CA  91767
Product CodePEM  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2020-12-23

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