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PEM — Dental Barriers And Sleeves Class II

FDA Device Classification

Classification Details

Product Code
PEM
Device Class
Class II
Regulation Number
878.4370
Submission Type
Review Panel
DE
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250735fomed industriesDental Barrier and SleevesJune 10, 2025
K250606yueying medical instruments (langfang) coDental Barrier and SleevesMay 29, 2025
K242435wellmed dental medical supply coDental Barrier and SleevesOctober 18, 2024
K233918yongqing huaguan dental instruments factoryDental Barrier and SleevesMay 9, 2024
K220662premium plus (dongguan) limitedDisposable Barrier SleevesMay 11, 2022
K211026minitubeMinitube Dentasleeve Protective Barrier SleevesAugust 3, 2021
K201604plasdent corporationPlasdent Disposable Barrier Sleeves and Barrier FilmDecember 23, 2020
K191448ivoclar vivadentBarrier SleevesOctober 8, 2019
K190484bh medical products coBH Medical Dental Barrier Sleeves and Barrier FilmSeptember 10, 2019
K190949air techniquesScanX Barrier EnvelopesJuly 26, 2019
K183263unipack medical corporationUNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier EnvelopeJune 14, 2019
K163447premium plus international limitedPremium Plus Disposable Barrier SleeveJune 20, 2017
K160232dentsply internationalDisposable Barrier Sleeves and CoversJune 7, 2016
K151123pac-dent internationalPac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmMarch 3, 2016
K132953tidi productsTIDISHEILDFebruary 18, 2014