Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

Dental Barriers And Sleeves

Pac-Dent International, Inc.

The following data is part of a premarket notification filed by Pac-dent International, Inc. with the FDA for Pac-dent Barrier Sleeve, Cover-it(tm) Barrier Film.

Pre-market Notification Details

Device IDK151123
510k NumberK151123
Device Name:Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
ClassificationDental Barriers And Sleeves
Applicant Pac-Dent International, Inc. 670 Endeavor Circle Brea,  CA  92821
ContactWenying Zhu
CorrespondentWenying Zhu
Pac-Dent International, Inc. 670 Endeavor Circle Brea,  CA  92821
Product CodePEM  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-28
Decision Date2016-03-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D702RT3004150 K151123 000
20302730002342 K151123 000
20302730002359 K151123 000
20302730002366 K151123 000
20302730002373 K151123 000
10302730002383 K151123 000
10302730002390 K151123 000
00723896018149 K151123 000
00723896018170 K151123 000
10302736700504 K151123 000
20302736701508 K151123 000
20302736702505 K151123 000
20302736703502 K151123 000
20302736704509 K151123 000
00815967025924 K151123 000

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