FDA Product Code
FDA Product Code PEM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4370
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262073 | Hygienic Protective Bite Cover (2207-010-50) | Dürr Dental SE | 2026-09-17 | Traditional | PDF ↗ |
| K261956 | Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | 2026-09-08 | Traditional | PDF ↗ |
| K250735 | Dental Barrier and Sleeves | Fomed Industries, Inc. | 2025-06-10 | Traditional | PDF ↗ |
| K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | 2025-05-29 | Traditional | PDF ↗ |
| K242435 | Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd. | 2024-10-18 | Traditional | PDF ↗ |
| K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | 2024-05-09 | Traditional | PDF ↗ |
| K220662 | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | 2022-05-11 | Traditional | PDF ↗ |
| K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | 2021-08-03 | Traditional | PDF ↗ |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | Plasdent Corporation | 2020-12-23 | Traditional | PDF ↗ |
| K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | 2019-10-08 | Traditional | PDF ↗ |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | 2019-09-10 | Traditional | PDF ↗ |
| K190949 | ScanX Barrier Envelopes | Air Techniques, Inc. | 2019-07-26 | Traditional | PDF ↗ |
| K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | 2019-06-14 | Traditional | PDF ↗ |
| K163447 | Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited | 2017-06-20 | Traditional | PDF ↗ |
| K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | 2016-06-07 | Traditional | PDF ↗ |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | 2016-03-03 | Traditional | PDF ↗ |
| K132953 | TIDISHEILD | Tidi Products,Llc | 2014-02-18 | Traditional | PDF ↗ |
Product code PEM · Class II · General, Plastic Surgery. Data: openFDA.