FDA 510(k) Applications for Medical Device Product Code "PEM"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K190949 | Air Techniques Inc. | ScanX Barrier Envelopes | 07/26/2019 |
| K190484 | BH Medical Products Co., Ltd. | BH Medical Dental Barrier Sleeves and Barrier Film | 09/10/2019 |
| K160232 | DENTSPLY International Inc. | Disposable Barrier Sleeves and Covers | 06/07/2016 |
| K191448 | Ivoclar Vivadent, AG | Barrier Sleeves | 10/08/2019 |
| K211026 | Minitube AB | Minitube Dentasleeve Protective Barrier Sleeves | 08/03/2021 |
| K151123 | Pac-Dent International, Inc. | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | 03/03/2016 |
| K201604 | Plasdent Corporation | Plasdent Disposable Barrier Sleeves and Barrier Film | 12/23/2020 |
| K220662 | Premium Plus (Dongguan) Limited | Disposable Barrier Sleeves | 05/11/2022 |
| K163447 | PREMIUM PLUS INTERNATIONAL LIMITED | Premium Plus Disposable Barrier Sleeve | 06/20/2017 |
| K132953 | TIDI PRODUCTS, LLC | TIDISHEILD | 02/18/2014 |
| K183263 | UNiPACK Medical Corporation | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | 06/14/2019 |
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