Dental Barriers And Sleeves
The Dental Barriers and Sleeves are disposable covers intended to serve as barriers for dental instruments and equipment surfaces to reduce the risk of cross-contamination between dental patients. They fall under the General and Plastic Surgery medical specialty (per the regulation classification) and are classified as a Class 2 device under regulation 878.4370, requiring 510(k) premarket notification. These single-use barriers are a fundamental infection control measure in dental practice. They are not implants and are not life-sustaining.
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Basic Information
- Product Code
- PEM
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Definition
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250735 | Dental Barrier and Sleeves | Jun 10, 2025 | Substantially Equivalent | Fomed Industries, Inc. |
| K250606 | Dental Barrier and Sleeves | May 29, 2025 | Substantially Equivalent | Yueying Medical Instruments (Langfang) Co., Ltd. |
| K242435 | Dental Barrier and Sleeves | Oct 18, 2024 | Substantially Equivalent | Wellmed Dental Medical Supply Co., Ltd. |
| K233918 | Dental Barrier and Sleeves | May 09, 2024 | Substantially Equivalent | Yongqing Huaguan Dental Instruments Factory |
| K220662 | Disposable Barrier Sleeves | May 11, 2022 | Substantially Equivalent | Premium Plus (Dongguan) Limited |
| K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Aug 03, 2021 | Substantially Equivalent | Minitube AB |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | Dec 23, 2020 | Substantially Equivalent | Plasdent Corporation |
| K191448 | Barrier Sleeves | Oct 08, 2019 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Sep 10, 2019 | Substantially Equivalent | Bh Medical Products Co., Ltd. |
| K190949 | ScanX Barrier Envelopes | Jul 26, 2019 | Substantially Equivalent | Air Techniques, Inc. |
| K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Jun 14, 2019 | Substantially Equivalent | Unipack Medical Corporation |
| K163447 | Premium Plus Disposable Barrier Sleeve | Jun 20, 2017 | Substantially Equivalent | Premium Plus International Limited |
| K160232 | Disposable Barrier Sleeves and Covers | Jun 07, 2016 | Substantially Equivalent | Dentsply International, Inc. |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Mar 03, 2016 | Substantially Equivalent | Pac-Dent International, Inc. |
| K132953 | TIDISHEILD | Feb 18, 2014 | Substantially Equivalent | Tidi Products,Llc |
FEI Numbers
This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.