Panels › General, Plastic Surgery › Product code PEM · Class 2
Dental Barriers And Sleeves
Regulation 878.4370
2510(k)s in 12 months (17 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PEM
| Company | 510(k)s | Recalls |
|---|---|---|
| Air Techniques, Inc. | 1 | 0 |
| ANI Co., Ltd. | 1 | 0 |
| Bh Medical Products Co., Ltd. | 1 | 0 |
| Dürr Dental SE | 1 | 0 |
| Dentsply International, Inc. | 1 | 0 |
| Fomed Industries, Inc. | 1 | 0 |
| Ivoclar Vivadent, AG | 1 | 0 |
| Minitube AB | 1 | 0 |
| Pac-Dent International, Inc. | 1 | 0 |
| Plasdent Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2026 | K262073 | Hygienic Protective Bite Cover (2207-010-50) Dürr Dental SE, DE | PEM |
| Sep 8, 2026 | K261956 | Dental Barriers and Sleeves (AB0006) ANI Co., Ltd., KR | PEM |
| Jun 10, 2025 | K250735 | Dental Barrier and Sleeves Fomed Industries, Inc., CN | PEM |
| May 29, 2025 | K250606 | Dental Barrier and Sleeves Yueying Medical Instruments (Langfang) Co., Ltd., CN | PEM |
| Oct 18, 2024 | K242435 | Dental Barrier and Sleeves Wellmed Dental Medical Supply Co., Ltd., CN | PEM |
| May 9, 2024 | K233918 | Dental Barrier and Sleeves Yongqing Huaguan Dental Instruments Factory, CN | PEM |
| May 11, 2022 | K220662 | Disposable Barrier Sleeves Premium Plus (Dongguan) Limited, CN | PEM |
| Aug 3, 2021 | K211026 | Minitube Dentasleeve Protective Barrier Sleeves Minitube AB, SE | PEM |
| Dec 23, 2020 | K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film Plasdent Corporation | PEM |
| Oct 8, 2019 | K191448 | Barrier Sleeves Ivoclar Vivadent, AG, LI | PEM |
| Sep 10, 2019 | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film Bh Medical Products Co., Ltd., CN | PEM |
| Jul 26, 2019 | K190949 | ScanX Barrier Envelopes Air Techniques, Inc. | PEM |
| Jun 14, 2019 | K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope Unipack Medical Corporation | PEM |
| Jun 20, 2017 | K163447 | Premium Plus Disposable Barrier Sleeve Premium Plus International Limited, CN | PEM |
| Jun 7, 2016 | K160232 | Disposable Barrier Sleeves and Covers Dentsply International, Inc. | PEM |
| Mar 3, 2016 | K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film Pac-Dent International, Inc. | PEM |
| Feb 18, 2014 | K132953 | TIDISHEILD Tidi Products,Llc | PEM |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.