PEM · Class II · 21 CFR 878.4370

FDA Product Code PEM: Dental Barriers And Sleeves

Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.

Leading manufacturers include Air Techniques, Inc., Ivoclar Vivadent, AG and Plasdent Corporation.

17
Total
17
Cleared
139d
Avg days
2014
Since
Growing category - 5 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 84d recently vs 162d historically

FDA 510(k) Cleared Dental Barriers And Sleeves Devices (Product Code PEM)

17 devices
1–17 of 17
Cleared Sep 17, 2026
Hygienic Protective Bite Cover (2207-010-50)
K262073
D?rr Dental SE
Dental · 87d
Cleared Sep 08, 2026
Dental Barriers and Sleeves (AB0006)
K261956
ANI Co., Ltd.
Dental · 89d
Cleared Jun 10, 2025
Dental Barrier and Sleeves
K250735
Fomed Industries, Inc.
Dental · 91d
Cleared May 29, 2025
Dental Barrier and Sleeves
K250606
Yueying Medical Instruments (Langfang) Co., Ltd.
Dental · 90d
Cleared Oct 18, 2024
Dental Barrier and Sleeves
K242435
Wellmed Dental Medical Supply Co., Ltd.
Dental · 63d
Cleared May 09, 2024
Dental Barrier and Sleeves
K233918
Yongqing Huaguan Dental Instruments Factory
Dental · 148d
Cleared May 11, 2022
Disposable Barrier Sleeves
K220662
Premium Plus (Dongguan) Limited
Dental · 65d
Cleared Aug 03, 2021
Minitube Dentasleeve Protective Barrier Sleeves
K211026
Minitube AB
Dental · 119d
Cleared Dec 23, 2020
Plasdent Disposable Barrier Sleeves and Barrier Film
K201604
Plasdent Corporation
General & Plastic Surgery · 191d
Cleared Oct 08, 2019
Barrier Sleeves
K191448
Ivoclar Vivadent, AG
Dental · 130d
Cleared Sep 10, 2019
BH Medical Dental Barrier Sleeves and Barrier Film
K190484
Bh Medical Products Co., Ltd.
General & Plastic Surgery · 195d
Cleared Jul 26, 2019
ScanX Barrier Envelopes
K190949
Air Techniques, Inc.
General & Plastic Surgery · 106d
Cleared Jun 14, 2019
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
K183263
Unipack Medical Corporation
General & Plastic Surgery · 203d
Cleared Jun 20, 2017
Premium Plus Disposable Barrier Sleeve
K163447
Premium Plus International Limited
Dental · 194d
Cleared Jun 07, 2016
Disposable Barrier Sleeves and Covers
K160232
Dentsply International, Inc.
Dental · 127d
Cleared Mar 03, 2016
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
K151123
Pac-Dent International, Inc.
Dental · 310d
Cleared Feb 18, 2014
TIDISHEILD
K132953
Tidi Products,Llc
Dental · 151d

About Product Code PEM - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code PEM since 2014, with 17 receiving FDA clearance (average review time: 139 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PEM Product Code

Recent submissions under PEM have taken an average of 84 days to reach a decision - down from 162 days historically, suggesting improved FDA processing for this classification.

PEM devices are reviewed by the Dental panel. Browse all Dental devices →