FDA product code PEM: Dental Barriers And Sleeves
PEM is the FDA product code for dental barriers and sleeves. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the Dental panel. FDA has cleared 17 510(k) submissions under PEM, 7 in the last five years, from 17 different applicants. The average 510(k) review took 139 days (median 127); 95 days on average over the last three years.
Definition
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Classification
| Field | Value |
|---|---|
| Device name | Dental Barriers And Sleeves |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | DE — Dental |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PEM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 194 |
| 2019 | 4 | 158 |
| 2020 | 1 | 191 |
| 2021 | 1 | 119 |
| 2022 | 1 | 65 |
| 2024 | 2 | 106 |
| 2025 | 2 | 90 |
| 2026 | 2 | 88 |
Compare with all 510(k) review times · Search every PEM clearance
Top PEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dürr Dental SE | 1 | 2026-09-17 |
| ANI Co., Ltd. | 1 | 2026-09-08 |
| Fomed Industries, Inc. | 1 | 2025-06-10 |
| Yueying Medical Instruments (Langfang) Co., Ltd. | 1 | 2025-05-29 |
| Wellmed Dental Medical Supply Co., Ltd. | 1 | 2024-10-18 |
12 more applicants have PEM clearances. See the full list in Caduvo.
Most recent PEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262073 | Dürr Dental SE | Hygienic Protective Bite Cover (2207-010-50) | 2026-09-17 | 87 |
| K261956 | ANI Co., Ltd. | Dental Barriers and Sleeves (AB0006) | 2026-09-08 | 89 |
| K250735 | Fomed Industries, Inc. | Dental Barrier and Sleeves | 2025-06-10 | 91 |
| K250606 | Yueying Medical Instruments (Langfang) Co., Ltd. | Dental Barrier and Sleeves | 2025-05-29 | 90 |
| K242435 | Wellmed Dental Medical Supply Co., Ltd. | Dental Barrier and Sleeves | 2024-10-18 | 63 |
Recalls for PEM devices
openFDA lists no recalls for product code PEM.
Frequently asked questions
What is FDA product code PEM?
PEM is the FDA product code for dental barriers and sleeves. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the Dental panel.
What device class is PEM?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEM?
Across 17 cleared submissions the average was 139 days from receipt to decision (median 127).
Which companies have the most PEM clearances?
Dürr Dental SE (1); ANI Co., Ltd. (1); Fomed Industries, Inc. (1); Yueying Medical Instruments (Langfang) Co., Ltd. (1); Wellmed Dental Medical Supply Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PEM
- Run a recall and safety report across every PEM manufacturer
- Watch product code PEM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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