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510(k) K220662

Device
Disposable Barrier Sleeves
Applicant
Premium Plus (Dongguan) Limited
510(k) number
K220662
Product code
PEM  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-11
Date received
2022-03-07
Regulation
878.4370
Classification name
Dental Barriers And Sleeves
Medical specialty
General & Plastic Surgery
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Jessica Mao
Address
#1 Industrial Area, Tutang, Changping Dongguan CN 523581 523581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PEM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250735Dental Barrier and SleevesFomed Industries, Inc.2025-06-10
K250606Dental Barrier and SleevesYueying Medical Instruments (Langfang) Co., Ltd.2025-05-29
K242435Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd.2024-10-18
K233918Dental Barrier and SleevesYongqing Huaguan Dental Instruments Factory2024-05-09
K211026Minitube Dentasleeve Protective Barrier SleevesMinitube AB2021-08-03
K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent Corporation2020-12-23
K191448Barrier SleevesIvoclar Vivadent, AG2019-10-08
K190484BH Medical Dental Barrier Sleeves and Barrier FilmBh Medical Products Co., Ltd.2019-09-10
K190949ScanX Barrier EnvelopesAir Techniques, Inc.2019-07-26
K183263UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeUnipack Medical Corporation2019-06-14
K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited2017-06-20
K160232Disposable Barrier Sleeves and CoversDentsply International, Inc.2016-06-07
K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPac-Dent International, Inc.2016-03-03
K132953TIDISHEILDTidi Products,Llc2014-02-18

Legacy Summary#

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FDA Review#

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