Dental Barriers And Sleeves
General, Plastic Surgery · 21 CFR 878.4370
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
69 firms currently registered for this product code
Ready Set Import
Beverly Hills, CA, US
Patterson Dental Supply, Inc.
ST. PAUL, MN, US
Oketz Logistics Llc
Coral Gables, FL, US
Yueying Medical Instruments (langfang) Co., Ltd.
Langfang City Hebei, CN
Young Innovations Inc.
Algonquin, IL, US
Dukal Llc
Ronkonkoma, NY, US
Zyris, Inc.
Santa Barbara, CA, US
Ibrite Suzhou Technology Co., Ltd
SUZHOU CITY Jiangsu, CN
Ismile Dental Products Inc.
Sacramento, CA, US
Yizur Ltd
Hong Kong, HK
Durr Optronik Gmbh & Co. Kg
Gechingen Baden-Wurttemberg, DE
Practicon, Inc.
Greenville, NC, US
Tianjin Water Source Tech Co., Ltd.
Tianjin, CN
Jmu Dental, Inc
Fullerton, CA, US
Ivoclar Vivadent Gmbh
Ellwangen Baden-Wurttemberg, DE
Maco Bag Corp.
Newark, NY, US
Suzhou Pac-dent Technology Co., Ltd
SUZHOU CITY Jiangsu, CN
Yongqing Huaguan Dental Instruments Factory
Langfang City Hebei, CN
Mouthwatch, Inc.
Metuchen, NJ, US
Premium Plus Dental Supplies Inc
BROOKLYN, NY, US
Nucare Llc
Montclair, CA, US
Inter-med, Inc.
Racine, WI, US
Zapalign Inc.
Anyang-si Gyeonggi, KR
510(k) clearances
15 clearances for this product code
- Fomed Industries, Inc.Jun 10, 2025
K250735 · Dental Barrier and Sleeves
- Yueying Medical Instruments (Langfang) Co., Ltd.May 29, 2025
K250606 · Dental Barrier and Sleeves
- Wellmed Dental Medical Supply Co., Ltd.Oct 18, 2024
K242435 · Dental Barrier and Sleeves
- Yongqing Huaguan Dental Instruments FactoryMay 9, 2024
K233918 · Dental Barrier and Sleeves
- Premium Plus (Dongguan) LimitedMay 11, 2022
K220662 · Disposable Barrier Sleeves
- Minitube ABAug 3, 2021
K211026 · Minitube Dentasleeve Protective Barrier Sleeves
- Plasdent CorporationDec 23, 2020
K201604 · Plasdent Disposable Barrier Sleeves and Barrier Film
- Ivoclar Vivadent, AGOct 8, 2019
K191448 · Barrier Sleeves