# Dental Barriers And Sleeves
> **Product code: PEM** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4370
## Classification
- **FDA Product Code:** PEM
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4370
- **Review panel:** DE
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

Intended to serve as a disposable  barrier for dental instruments to reduce  the risk of cross contamination between dental patients.

## Market data
- **Cleared 510(k) submissions:** 15
- **Registered establishments:** 45
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PEM)
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