# PEM: Dental Barriers And Sleeves

- Device class: 2; regulation: 21 CFR 878.4370; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 91 days (middle half 71–112)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2016: 2
- 2017: 1
- 2019: 4
- 2020: 1
- 2021: 1
- 2022: 1
- 2024: 2
- 2025: 2
- 2026: 2

## Most-cited predicates
- K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film (2016), cited by 4
- K132953: Tidisheild (2014), cited by 3
- K190484: BH Medical Dental Barrier Sleeves and Barrier Film (2019), cited by 3
- K160232: Disposable Barrier Sleeves and Covers (2016), cited by 2
- K233918: Dental Barrier and Sleeves (2024), cited by 1
- K250606: Dental Barrier and Sleeves (2025), cited by 1
- K163447: Premium Plus Disposable Barrier Sleeve (2017), cited by 1
- K191448: Barrier Sleeves (2019), cited by 1

Source page: https://510kreport.com/product-code/PEM
Data by year (CSV): https://510kreport.com/product-code/PEM.csv