PEM — Dental Barriers And Sleeves Class II
FDA product code PEM covers "Dental Barriers And Sleeves", a Class II medical device regulated under 21 CFR 878.4370. Submissions are reviewed by the General, Plastic Surgery panel. At least 15 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250735 | fomed industries | Dental Barrier and Sleeves | June 10, 2025 |
| K250606 | yueying medical instruments (langfang) co | Dental Barrier and Sleeves | May 29, 2025 |
| K242435 | wellmed dental medical supply co | Dental Barrier and Sleeves | October 18, 2024 |
| K233918 | yongqing huaguan dental instruments factory | Dental Barrier and Sleeves | May 9, 2024 |
| K220662 | premium plus (dongguan) limited | Disposable Barrier Sleeves | May 11, 2022 |
| K211026 | minitube | Minitube Dentasleeve Protective Barrier Sleeves | August 3, 2021 |
| K201604 | plasdent corporation | Plasdent Disposable Barrier Sleeves and Barrier Film | December 23, 2020 |
| K191448 | ivoclar vivadent | Barrier Sleeves | October 8, 2019 |
| K190484 | bh medical products co | BH Medical Dental Barrier Sleeves and Barrier Film | September 10, 2019 |
| K190949 | air techniques | ScanX Barrier Envelopes | July 26, 2019 |
| K183263 | unipack medical corporation | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | June 14, 2019 |
| K163447 | premium plus international limited | Premium Plus Disposable Barrier Sleeve | June 20, 2017 |
| K160232 | dentsply international | Disposable Barrier Sleeves and Covers | June 7, 2016 |
| K151123 | pac-dent international | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | March 3, 2016 |
| K132953 | tidi products | TIDISHEILD | February 18, 2014 |